The Alma Hybrid Laser System

K251230 · Alma Lasers, Inc. · GEX · May 21, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K251230
• Device Name: The Alma Hybrid Laser System
• Applicant: Alma Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 21, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alma Hybrid Laser System (Pixel and HyLight CO2 Applicators) is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee). The Alma Hybrid Laser System is cleared for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: Laser skin resurfacing Laser dermabrasion Laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for the treatment of: Wrinkles, rhytids, and furrows (including fines lines and texture irregularities) Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: Keratoses, including actinic and seborrheic keratosis, seborrheic vulgaris, seborrheic wart, and verruca seborrhoica; Vermilionectomy of the lip; Cutaneous horns; Solar/actinic elastosis; Cheilitis, including actinic cheilitis; Lentigines, including lentigo maligna or Hutchinson’s malignant freckle; Uneven pigmentation/ dyschromia; Acne scars; Surgical scars; Keloids including acne keloidalis nuchae; Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum); Tattoos; Telangiectasia; Removal of small skin tumors, including periungual (Koenen) and subungual fibromas; Superficial pigmented lesions; Aden sebaceous hypertrophy or sebaceous hyperplasia; Rhinophyma reduction; Cutaneous papilloma (skin tags); Milia; Debridement of eczematous or infected skin; Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; Nevi, including spider, epidermal and protruding; Neurofibromas; Laser de-epithelialization; Trichoepitheliomas; Xanthelasma Palpebrarum; Syringoma Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of: Benign/malignant vascular/avascular skin lesions; Moh's Surgery; Lipectomy; Verrucae and seborrheic vulgaris, including paronychial, perifungal, and subungual warts. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation. Podiatry Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of: Verrucae vulgaris/plantar (warts), including paronychial, perifungal, and subungual warts; Fungal nail treatment; Porokeratoma ablation; Ingrown nail treatment; Neuromas/fibromas, including Morton's neuroma; Debridement of ulcers; Other soft tissue lesions. Otolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of: Choanal atresia, Leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue; Nasal obstruction; Adult and juvenile papillomatosis polyps; Polypectomy of nose and nasal passages; Lymphangioma removal; Removal of vocal cord/fold nodules, polyps and cysts; Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords; Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structure and tissue Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophageal diverticulectomy (ELAED)]; Stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy; Pulmonary bronchial and tracheal lesion removal; Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial); Benign and malignant lesions and fibromas (nose and nasal passages); Benign and malignant tumors and fibromas; (oral); Stapedotomy/stapedectomy; Acoustic neuroma in the ear; Superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler’s disease; Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue); Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea; Myringotomy/tympanostomy (tympanic membrane fenestration); Uvulopalatoplasty (LAUP, laser UPPP); Turbinectomy and turbinate reduction/ablation); Septal spur ablation/reduction and septoplasty; Partial glossectomy; Tumor resection on oral, subfascial and neck tissues; Rhinophyma; Verrucae vulgaris (warts); Gingivoplasty/gingivectomy. Gynecology (GYN) Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of: Conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); Condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen’s disease, (Erythroplasia of Queyrat) and Bowenoid papulosis (BP) lesions; Leukoplakia (vulvar dystrophies); Incision and drainage (I&D) of Bartholin’s and Nabothian cysts; Herpes vaporization; Urethral caruncle vaporization; Cervical dysplasia; Benign and malignant tumors; Hemangiomas GYN Laparoscopy Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of: Endometrial lesions, including ablation of endometriosis; Excision/lysis of adhesions; Salpingostomy Oophorectomy/ovariectomy; Fimbrioplasty; Metroplasty; Microsurgery (tubal); Uterine myomas and fibroids; Ovarian fibromas and follicle cysts; Uterosacral ligament ablation; Hysterectomy Neurosurgery Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of: Cranial Posterior fossa tumors; Peripheral neurectomy; Benign and malignant tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors); Arteriovenous malformation; Pituitary gland tumors (transsphenoidal approach). Spinal Cord Incision/excision and vaporization of benign and malignant tumors and cysts; Intra- and extradural lesions; Laminectomy/ laminotomy/ microdiscectomy. Orthopedics Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include: Arthroscopy Meniscectomy; Chondromalacia; Chondroplasty; Ligament release (lateral and other); Excision of plica; Partial synovectomy. General Debridement of traumatic wounds; Debridement of decubitus and diabetic ulcers; Microsurgery; Artificial joint revision; PMMA removal. General/Thoracic Surgery Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include: Debridement of decubitus ulcers, stasis, diabetic and other ulcers; Mastectomy; Debridement of burns; Rectal and anal hemorrhoidectomy; Breast biopsy; Reduction mammoplasty; Cytoreduction for metastatic disease; Laparotomy and laparoscopic applications; Mediastinal and thoracic lesions and abnormalities; Skin tag vaporization; Atheroma; Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; Pilonidal cyst removal and repair; Abscesses; Other soft tissue applications. Dental/Oral Surgery Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: Gingivectomy- removal of hyperplasia; Gingivoplasty; Incisional and excisional biopsy; Treatment of ulcerous lesions, including aphthous ulcers; Incision of infection when used with antibiotic therapy; Frenectomy (frenum release); Excision and ablation of benign and malignant lesions; Homeostasis; Operculectomy; Crown lengthening; Removal of soft tissue, cysts and tumors; Oral cavity tumors and hemangiomas; Abscesses; Extraction site hemostasis; Salivary gland pathologies; Pre-prosthetic gum preparation; Leukoplakia; Partial glossectomy; Periodontal gum resection. Genitourinary Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include: Benign and malignant lesions of external genitalia; Condyloma; Phimosis Erythroplasia ProScan The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for: Laser skin resurfacing (ablation and/or vaporization) of soft tissue. The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

Device Story

The Alma Hybrid Laser System is a multi-wavelength (CO2 10600 nm and 1570 nm) surgical laser console featuring an articulated arm, footswitch, and various delivery applicators (Pixel, HyLight, ProScan). Operated by clinicians in clinical settings, the system uses an optical bench assembly and microcontroller-based electronics to deliver laser energy for soft tissue ablation, vaporization, excision, incision, and coagulation. The user interacts via an LCD touch-screen to set parameters (e.g., pulse duration, repetition rate, energy). The device transforms electrical power into controlled laser output, enabling precise tissue interaction for diverse surgical specialties. Clinical benefits include effective tissue management for conditions ranging from dermatological resurfacing to complex neurosurgical and orthopedic procedures. The system is designed for professional use, with output parameters affecting clinical decision-making regarding tissue removal and healing.

Clinical Evidence

No human clinical studies were performed for this submission. Substantial equivalence is supported by the similarity in safety and effectiveness profiles to the predicate devices. Bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and laser safety (IEC 60825-1), was previously conducted under K230441.

Technological Characteristics

System utilizes CO2 (10600 nm) and 1570 nm laser sources. Features articulated arm delivery, LCD touch-screen interface, and microcontroller-based control. Applicators include Pixel, HyLight, and ProScan. Operates in repeat pulse/CW modes. Safety standards met: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-1, ISO 17665-1, IEC 62304, ISO 14971.

Indications for Use

Indicated for surgical soft tissue ablation, vaporization, excision, incision, and coagulation in dermatology, plastic surgery, podiatry, otolaryngology, gynecology, neurosurgery, orthopedics, general/thoracic surgery, dental/oral surgery, and genitourinary procedures. Specific applications include skin resurfacing, lesion removal, tumor resection, and various endoscopic/laparoscopic procedures.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Alma Hybrid (K203441)

Reference Devices

• Alma Lasers Pixel CO2 Laser System (K103501)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 21, 2025

Alma Lasers, Inc
Jessica Rivera-Montejo
Director - Regulatory Affairs and Quality Assurance
485 Half Day Rd
Suite 100
Buffalo Grove, Illinois 60089

Re: K251230
Trade/Device Name: The Alma Hybrid Laser System
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: GEX, ONG
Dated: March 27, 2025
Received: April 21, 2025

Dear Jessica Rivera-Montejo:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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2K251230 - Jessica Rivera-Montejo
Page

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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3K251230 - Jessica Rivera-Montejo
Page

Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

TANISHA
L. HITHE -S

Digitally signed by
TANISHA L. HITHE
Date: 2025.05.21
14:56:41 -04'00'

Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K251230

Device Name
The Alma Hybrid Laser System

Indications for Use (Describe)
The Alma Hybrid Laser System (Pixel and HyLight CO2 Applicators) is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee). The Alma Hybrid Laser System is cleared for use for the particular indications as follows:

Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
of soft tissue in dermatology and plastic surgery in the performance of:
- Laser skin resurfacing
- Laser dermabrasion
- Laser burn debridement.

Laser skin resurfacing (ablation and/or vaporization) for the treatment of:
- Wrinkles, rhytids, and furrows (including fines lines and texture irregularities)

Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- Keratoses, including actinic and seborrheic keratosis, seborrheic vulgaris, seborrheic wart, and verruca seborrhoica;
- Vermilionectomy of the lip;
- Cutaneous horns;
- Solar/actinic elastosis;
- Cheilitis, including actinic cheilitis;
- Lentigines, including lentigo maligna or Hutchinson’s malignant freckle;
- Uneven pigmentation/ dyschromia;
- Acne scars;
- Surgical scars;
- Keloids including acne keloidalis nuchae;
- Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum);
- Tattoos;
- Telangiectasia;
- Removal of small skin tumors, including periungual (Koenen) and subungual fibromas;
- Superficial pigmented lesions;
- Aden sebaceous hypertrophy or sebaceous hyperplasia;
- Rhinophyma reduction;
- Cutaneous papilloma (skin tags);
- Milia;
- Debridement of eczematous or infected skin;

FORM FDA 3881 (8/23)
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PSC Publishing Services [phone]

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- Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions;
- Nevi, including spider, epidermal and protruding;
- Neurofibromas;
- Laser de-epithelialization;
- Trichoepitheliomas;
- Xanthelasma Palpebrarum;
- Syringoma

Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy.

Vaporization/coagulation of:
- Benign/malignant vascular/avascular skin lesions;
- Moh's Surgery;
- Lipectomy;
- Verrucae and seborrheic vulgaris, including paronychial, perifungal, and subungual warts.

Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.

Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.

Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

## Podiatry

## Podiatry

Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:
- Verrucae vulgaris/plantar (warts), including paronychial, perifungal, and subungual warts;
- Fungal nail treatment;
- Porokeratoma ablation;
- Ingrown nail treatment;
- Neuromas/fibromas, including Morton's neuroma;
- Debridement of ulcers;
- Other soft tissue lesions.

## Otolaryngology (ENT)

Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
- Choanal atresia,
- Leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue;
- Nasal obstruction;
- Adult and juvenile papillomatosis polyps;
- Polypectomy of nose and nasal passages;
- Lymphangioma removal;
- Removal of vocal cord/fold nodules, polyps and cysts;
- Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;
- Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structure and tissue
- Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophageal diverticulectomy (ELAED)];
- Stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy;
- Pulmonary bronchial and tracheal lesion removal;

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- Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial);
- Benign and malignant lesions and fibromas (nose and nasal passages);
- Benign and malignant tumors and fibromas; (oral);
- Stapedotomy/stapedectomy;
- Acoustic neuroma in the ear;
- Superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler’s disease;
- Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue);
- Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea;
- Myringotomy/tympanostomy (tympanic membrane fenestration);
- Uvulopalatoplasty (LAUP, laser UPPP);
- Turbinectomy and turbinate reduction/ablation);
- Septal spur ablation/reduction and septoplasty;
- Partial glossectomy;
- Tumor resection on oral, subfascial and neck tissues;
- Rhinophyma;
- Verrucae vulgaris (warts);
- Gingivoplasty/gingivectomy.

## Gynecology (GYN)

Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:

- Conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
- Condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen’s disease, (Erythroplasia of Queyrat) and Bowenoid papulosis (BP) lesions;
- Leukoplakia (vulvar dystrophies);
- Incision and drainage (I&D) of Bartholin’s and Nabothian cysts;
- Herpes vaporization;
- Urethral caruncle vaporization;
- Cervical dysplasia;
- Benign and malignant tumors;
- Hemangiomas

## GYN Laparoscopy

Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:

- Endometrial lesions, including ablation of endometriosis;
- Excision/lysis of adhesions;
- Salpingostomy
- Oophorectomy/ovariectomy;
- Fimbrioplasty;
- Metroplasty;
- Microsurgery (tubal);
- Uterine myomas and fibroids;
- Ovarian fibromas and follicle cysts;
- Uterosacral ligament ablation;
- Hysterectomy

## Neurosurgery

Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the

FORM FDA 3881 (8/23)
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treatment of:

**Cranial**
- Posterior fossa tumors;
- Peripheral neurectomy;
- Benign and malignant tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors);
- Arteriovenous malformation;
- Pituitary gland tumors (transsphenoidal approach).

**Spinal Cord**
- Incision/excision and vaporization of benign and malignant tumors and cysts;
- Intra- and extradural lesions;
- Laminectomy/ laminotomy/ microdiscectomy.

**Orthopedics**
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:

**Arthroscopy**
- Meniscectomy;
- Chondromalacia;
- Chondroplasty;
- Ligament release (lateral and other);
- Excision of plica;
- Partial synovectomy.

**General**
- Debridement of traumatic wounds;
- Debridement of decubitus and diabetic ulcers;
- Microsurgery;
- Artificial joint revision;
- PMMA removal.

**General/Thoracic Surgery**
Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:
- Debridement of decubitus ulcers, stasis, diabetic and other ulcers;
- Mastectomy;
- Debridement of burns;
- Rectal and anal hemorrhoidectomy;
- Breast biopsy;
- Reduction mammoplasty;
- Cytoreduction for metastatic disease;
- Laparotomy and laparoscopic applications;
- Mediastinal and thoracic lesions and abnormalities;
- Skin tag vaporization;
- Atheroma;
- Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips;
- Pilonidal cyst removal and repair;
- Abscesses;
- Other soft tissue applications.

**Dental/Oral Surgery**
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- Gingivectomy- removal of hyperplasia;
- Gingivoplasty;

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PSC Publishing Services [phone]

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- Incisional and excisional biopsy;
- Treatment of ulcerous lesions, including aphthous ulcers;
- Incision of infection when used with antibiotic therapy;
- Frenectomy (frenum release);
- Excision and ablation of benign and malignant lesions;
- Homeostasis;
- Operculectomy;
- Crown lengthening;
- Removal of soft tissue, cysts and tumors;
- Oral cavity tumors and hemangiomas;
- Abscesses;
- Extraction site hemostasis;
- Salivary gland pathologies;
- Pre-prosthetic gum preparation;
- Leukoplakia;
- Partial glossectomy;
- Periodontal gum resection.

## Genitourinary

Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:

- Benign and malignant lesions of external genitalia;
- Condyloma;
- Phimosis
- Erythroplasia

## ProScan

The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for: Laser skin resurfacing (ablation and/or vaporization) of soft tissue.

The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue

The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (8/23)
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PSC Publishing Services [phone]

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K251230 - Special 510(k) Summary

A summary of Special 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

I. Submitter Information [21 CFR 807.92(a) (1)]

| Owner Name | Alma Lasers Inc. |
| --- | --- |
| Address | 18 Haharash Street
NORTH INDUSTRIAL PARK
CAESAREA, IL 3079895 |
| Contact Person | Jessica Rivera-Montejo Assoc. Director of Regulatory
Email: [e-mail]
Phone: [phone]
Facsimile: 646-805-1305 |
| Summary Preparation Date | 27 March 2025 |

II. Name of device [21 CFR 807.92 (a) (2)]

| Trade or Proprietary Name | The Alma Hybrid Laser System | | |
| --- | --- | --- | --- |
| Common Device Name(s) and Regulatory Class | Product Code(s) | Classification Panel | Regulation |
| Electrosurgical cutting and coagulation device and accessories Class II | GEX | General & Plastic Surgery Panel, 79 (SU) | § 21 CFR 878.4810 |
| Powered Laser Surgical Instrument with Microbeam\Fractional Output | ONG | General & Plastic Surgery Panel, 79 (SU) | § 21 CFR 878.4810 |

III. Predicate Devices [21 CFR 807.92(a) (3)]

| Type | 510(k) # | Trade Name | Product Code |
| --- | --- | --- | --- |
| Primary | K203441 | Alma Hybrid | GEX |
| Reference | K103501 | Alma Lasers Pixel CO2 Laser System | GEX |

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Special 510(k) Summary

## IV. Device Description [21 CFR 807.92(a) (4)]

The Alma Hybrid Laser System consists of:

- Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)
- LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of The Alma Hybrid Laser System with touch-screen technology provided to input commands into the system.
- Two wavelengths – CO2 and 1570 nm
- Articulated arm
- Footswitch
- Delivery devices (Pixel applicators, Hylight applicators, Proscan applicator)

## V. Intended use of device and Indications for Use [21 CFR 807.92(a) (5)]

### Intended Use

The Alma Hybrid Laser System (Pixel and HyLight CO2 Applicators) is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee). The Alma Hybrid Laser System is cleared for use for the particular indications as follows:

### Dermatology & Plastic Surgery

The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

of soft tissue in dermatology and plastic surgery in the performance of:

- Laser skin resurfacing
- Laser dermabrasion
- Laser burn debridement.

Laser skin resurfacing (ablation and/or vaporization) for the treatment of:

- Wrinkles, rhytids, and furrows (including fines lines and texture irregularities)

Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:

- Keratoses, including actinic and seborrheic keratosis, seborrheic vulgaris, seborrheic wart, and verruca seborrhoica;
- Vermilionectomy of the lip;
- Cutaneous horns;
- Solar/actinic elastosis;
- Cheilitis, including actinic cheilitis;
- Lentigines, including lentigo maligna or Hutchinson's malignant freckle;
- Uneven pigmentation/ dyschromia;

Premarket Notification, Special 510(k) Alma Hybrid Laser System

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Special 510(k) Summary

- Acne scars;
- Surgical scars;
- Keloids including acne keloidalis nuchae;
- Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum);
- Tattoos;
- Telangiectasia;
- Removal of small skin tumors, including periungual (Koenen) and subungual fibromas;
- Superficial pigmented lesions;
- Aden sebaceous hypertrophy or sebaceous hyperplasia;
- Rhinophyma reduction;
- Cutaneous papilloma (skin tags);
- Milia;
- Debridement of eczematous or infected skin;
- Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions;
- Nevi, including spider, epidermal and protruding;
- Neurofibromas;
- Laser de-epithelialization;
- Trichoepitheliomas;
- Xanthelasma Palpebrarum;
- Syringoma

Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy.

Vaporization/coagulation of:

- Benign/malignant vascular/avascular skin lesions;
- Moh's Surgery;
- Lipectomy;
- Verrucae and seborrheic vulgaris, including paronychial, perifungal, and subungual warts.

Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.

Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.

Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

## Podiatry

Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:

- Verrucae vulgaris/plantar (warts), including paronychial, perifungal, and subungual warts;
- Fungal nail treatment;
- Porokeratoma ablation;
- Ingrown nail treatment;
- Neuromas/fibromas, including Morton's neuroma;
- Debridement of ulcers;
- Other soft tissue lesions.

Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.

Premarket Notification, Special 510(k) Alma Hybrid Laser System

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Special 510(k) Summary

# Otolaryngology (ENT)

Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:

- Choanal atresia,
- Leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue;
- Nasal obstruction;
- Adult and juvenile papillomatosis polyps;
- Polypectomy of nose and nasal passages;
- Lymphangioma removal;
- Removal of vocal cord/fold nodules, polyps and cysts;
- Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;
- Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structure and tissue
- Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophageal diverticulectomy (ELAED)];
- Stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy;
- Pulmonary bronchial and tracheal lesion removal;
- Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial);
- Benign and malignant lesions and fibromas (nose and nasal passages);
- Benign and malignant tumors and fibromas; (oral);
- Stapedotomy/stapedectomy;
- Acoustic neuroma in the ear;
- Superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease;
- Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue);
- Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea;
- Myringotomy/tympanostomy (tympanic membrane fenestration);
- Uvulopalatoplasty (LAUP, laser UPPP);
- Turbinectomy and turbinate reduction/ablation);
- Septal spur ablation/reduction and septoplasty;
- Partial glossectomy;
- Tumor resection on oral, subfascial and neck tissues;
- Rhinophyma;
- Verrucae vulgaris (warts);
- Gingivoplasty/gingivectomy.

# Gynecology (GYN)

Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:

- Conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
- Condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosis (BP) lesions;
- Leukoplakia (vulvar dystrophies);
- Incision and drainage (I&D) of Bartholin's and Nabothian cysts;

Premarket Notification, Special 510(k) Alma Hybrid Laser System

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Special 510(k) Summary

- Herpes vaporization;
- Urethral caruncle vaporization;
- Cervical dysplasia;
- Benign and malignant tumors;
- Hemangiomas.

# GYN Laparoscopy

Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:

- Endometrial lesions, including ablation of endometriosis;
- Excision/lysis of adhesions;
- Salpingostomy
- Oophorectomy/ovariectomy;
- Fimbrioplasty;
- Metroplasty;
- Microsurgery (tubal);
- Uterine myomas and fibroids;
- Ovarian fibromas and follicle cysts;
- Uterosacral ligament ablation;
- Hysterectomy.

# Neurosurgery

Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:

## Cranial

- Posterior fossa tumors;
- Peripheral neurectomy;
- Benign and malignant tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors);
- Arteriovenous malformation;
- Pituitary gland tumors (transsphenoidal approach).

## Spinal Cord

- Incision/excision and vaporization of benign and malignant tumors and cysts;
- Intra- and extradural lesions;
- Laminectomy/ laminotomy/ microdiscectomy.

# Orthopedics

Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:

## Arthroscopy

- Meniscectomy;
- Chondromalacia;
- Chondroplasty;
- Ligament release (lateral and other);
- Excision of plica;
- Partial synovectomy.

# General

- Debridement of traumatic wounds;
- Debridement of decubitus and diabetic ulcers;

Premarket Notification, Special 510(k) Alma Hybrid Laser System

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Special 510(k) Summary

- Microsurgery;
- Artificial joint revision;
- PMMA removal.

## General/Thoracic Surgery

Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:

- Debridement of decubitus ulcers, stasis, diabetic and other ulcers;
- Mastectomy;
- Debridement of burns;
- Rectal and anal hemorrhoidectomy;
- Breast biopsy;
- Reduction mammoplasty;
- Cytoreduction for metastatic disease;
- Laparotomy and laparoscopic applications;
- Mediastinal and thoracic lesions and abnormalities;
- Skin tag vaporization;
- Atheroma;
- Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips;
- Pilonidal cyst removal and repair;
- Abscesses;
- Other soft tissue applications.

## Dental/Oral Surgery

Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:

- Gingivectomy- removal of hyperplasia;
- Gingivoplasty;
- Incisional and excisional biopsy;
- Treatment of ulcerous lesions, including aphthous ulcers;
- Incision of infection when used with antibiotic therapy;
- Frenectomy (frenum release);
- Excision and ablation of benign and malignant lesions;
- Homeostasis;
- Operculectomy;
- Crown lengthening;
- Removal of soft tissue, cysts and tumors;
- Oral cavity tumors and hemangiomas;
- Abscesses;
- Extraction site hemostasis;
- Salivary gland pathologies;
- Pre-prosthetic gum preparation;
- Leukoplakia;
- Partial glossectomy;
- Periodontal gum resection.

## Genitourinary

Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:

- Benign and malignant lesions of external genitalia;
- Condyloma;

Premarket Notification, Special 510(k) Alma Hybrid Laser System

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Special 510(k) Summary

- Phimosis
- Erythroplasia

## ProScan

The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for: Laser skin resurfacing (ablation and/or vaporization) of soft tissue.

The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue

The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

Premarket Notification, Special 510(k) Alma Hybrid
Laser System
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Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | Hybrid-Hylight Applicator | Hybrid-Hylight Applicator K203441 | Alma Pixel CO2 (K103501) | |
| Wavelength | 10600 nm | 10600 nm | 10600 nm | Same |
| Pilot beam | 650 nm, 3mW | 650 nm, 3mW | 650 nm, <5 mW | Same |
| Operation Mode | Repeat pulse/CW | Repeat pulse/CW | Repeat/Super Pulse/CW | Same – |
| Spot size (mm) | 0.15 – 3.1 mm | 0.15-3.1 mm | 0.125 mm dia spot at tip of spatula at 50 mm working distance 0.2mm dia. Spot at tip of spatula at 100 mm working distance | Same |
| Repetition Rate | 1-5 Hz | 1-5 Hz | CW 1-5 Hz | Same |
| Pulse Duration | 10-1000 ms | 10-1000 ms | 10-1000 ms for CW | Same |
| Repeat Delay | CW On time: 10 - 1000 msec (0.01 – 1 sec) NA | CW On time: 10 - 1000 msec (0.01 – 1 sec) NA | CW On time: 10 - 1000 msec (0.01 – 1 sec) | Same |
| Min output energy | 5 mJ | 5 mJ | 1 mJ | Same |
| Fluence | Max 1746 J/mm2 for 30W system
Max 3530 J/mm2 for the 70W system | Max 1746 J/mm2 for 30W system
Max 3530 J/mm2 for the 70W system | Max 1746 J/mm2 for 30W system
Max 3530 J/mm2 for the 70W system | Same |

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Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| Spot size (mm) | Pixel Applicator- 0.125 to 0.20 mm dia. pixels in a 10 x10 mm2 area (49 pixels) @ 50 mm distance - 0.125 to 0.20 mm dia. pixels in a 11 x 11 mm2 area (81 pixels) @ 100 mm distance | Pixel Applicator- 0.125 to 0.20 mm dia. pixels in a 10 x10 mm2 area (49 pixels) @ 50 mm distance - 0.125 to 0.20 mm dia. pixels in a 11 x 11 mm2 area (81 pixels) @ 100 mm distance | Pixel Applicator- 0.125 to 0.20 mm dia. pixels in a 10 x10 mm2 area (49 pixels) @ 50 mm distance - 0.125 to 0.20 mm dia. pixels in a 11 x 11 mm2 area (81 pixels) @ 100 mm distance | Same |
| Repetition Rate | 0.5-2Hz | 0.5-2Hz | 1-5 Hz | Same |
| Pulse Duration | 1- 405 ms | 1- 405 ms | 100-300 ms for pulsed | Same |
| Min output energy | 5 mJ/pixel | 5 mJ/pixel | Up to 1000 mJ | Same |
| Max output energy | SW limited to 150 mJ/pixel | SW limited to 150 mJ/pixel | Up to 1000 mJ SW limited to 150 | Same |
| Output Power | 30 W, 70W | 30 W, 70W | 30 W, 70W | Same |
| Wavelength | 1570nm- For ProScan Applicator | 1570nm- For ProScan Applicator | N/A | Same as Primary Predicate |
| Scan size (mm) | Up to 30mm diameter | Up to 30mm diameter | N/A | Same as Primary Predicate |
| Output energy | 24mJ-144mJ/pixel | 24mJ-144mJ/pixel | N/A | Same as Primary Predicate |

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Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| Indications for Use | The Alma Hybrid Laser System (Pixel and HyLight CO2 Applicators) is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee). The Alma Hybrid Laser System is cleared for use for the particular indications as follows:

**Dermatology & Plastic Surgery**
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
• Laser skin resurfacing
• Laser dermabrasion | The Alma Hybrid Laser System and Accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).
HyLight-CO2
The Alma Hybrid CO2 non-fractional applicator, with wavelength of 10600 nm is cleared for use for the particular indications as follows:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
* laser skin resurfacing
* laser derm-abrasion
* laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma.
Vaporization/coagulation of warts. | The Alma Pixel CO2 Laser System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee). The Alma Hybrid Laser System is cleared for use for the particular indications as follows:

**Dermatology & Plastic Surgery**
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
• Laser skin resurfacing | Same as the Reference Predicate |

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Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | ·Laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for the treatment of: ·Wrinkles, rhytids, and furrows (including fines lines and texture irregularities) Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: ·Keratoses, including actinic and seborrheic keratosis, seborrheic vulgaris, | Pixel The Alma Hybrid Pixel CO2 fractional applicator, with wavelength 10600 nm is indicated for: The ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery in the performance of skin resurfacing. ProScan The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for: ·Laser skin resurfacing (ablation and/or vaporization) of soft tissue The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: ·Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue. | ·Laser dermabrasion ·Laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for the treatment of: ·Wrinkles, rhytids, and furrows (including fines lines and texture irregularities) Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: ·Keratoses, including actinic | |

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Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | seborrheic wart, and verruca seborrhoica;
• Vermilionectomy of the lip;
• Cutaneous horns;
• Solar/actinic elastosis;
• Cheilitis, including actinic cheilitis;
• Lentigines, including lentigo maligna or Hutchinson’s malignant freckle;
• Uneven pigmentation/dyschromia;
• Acne scars;
• Surgical scars;
• Keloids including acne keloidalis nuchae;
• Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma | | and seborrheic keratosis, seborrheic vulgaris, seborrheic wart, and verruca seborrhoica;
• Vermilionectomy of the lip;
• Cutaneous horns;
• Solar/actinic elastosis;
• Cheilitis, including actinic cheilitis;
• Lentigines, including lentigo maligna or Hutchinson’s malignant freckle;
• Uneven pigmentation/dyschromia;
• Acne scars;
• Surgical scars;
• Keloids including acne | |

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Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | pyogenicum/granuloma telagiectaticum);
• Tattoos;
• Telangiectasia;
• Removal of small skin tumors, including periungual (Koenen) and subungual fibromas;
• Superficial pigmented lesions;
• Aden sebaceous hypertrophy or sebaceous hyperplasia;
• Rhinophyma reduction;
• Cutaneous papilloma (skin tags);
• Milia;
• Debridement of eczematous or infected skin;
• Basal and squamous cell carcinoma, | | keloidalis nuchae;
• Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum);
• Tattoos;
• Telangiectasia;
• Removal of small skin tumors, including periungual (Koenen) and subungual fibromas;
• Superficial pigmented lesions;
• Aden sebaceous hypertrophy or sebaceous hyperplasia; | |

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Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | including
keratoacanthomas,
Bowen's disease
(Erythroplasia of
Queyrat), and
Bowenoid
Papulosis (BP)
lesions;
• Nevi, including
spider, epidermal
and protruding;
• Neurofibromas;
• Laser de-epithelialization;
• Trichoepithelioma
s;
• Xanthelasma
Palpebrarum;
• Syringoma

Laser ablation,
vaporization and /or
excision for complete or
partial nail matrixectomy.
Vaporization/coagulation
of:
• Benign/malignant
vascular/avascular
skin lesions;
• Moh’s Surgery;
• Lipectomy; | | • Rhinophyma
reduction;
• Cutaneous
papilloma (skin
tags);
• Milia;
• Debridement of
eczematous or
infected skin;
• Basal and
squamous cell
carcinoma,
including
keratoacanthoma
s, Bowen's
disease
(Erythroplasia of
Queyrat), and
Bowenoid
Papulosis (BP)
lesions;
• Nevi, including
spider,
epidermal and
protruding;
• Neurofibromas;
• Laser de-epithelialization;
• Trichoepithelioma; | |

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Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | • Verrucae and seborrheic vulgaris, including paronychial, perifungal, and subungual warts.
Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.
Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.
**Podiatry**
Laser ablation, vaporization and /or excision of soft tissue for | | • Xanthelasma Palpebrarum;
• Syringoma
Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy.
Vaporization/coagulation of:
• Benign/malignant vascular/avascular skin lesions;
• Moh’s Surgery;
• Lipectomy;
• Verrucae and seborrheic vulgaris, including paronychial, perifungal, and subungual warts.
Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and /or | |

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Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | the reduction, removal, and/or treatment of:
• Verrucae vulgaris/plantar (warts), including paronychial, perifungal, and subungual warts;
• Fungal nail treatment;
• Porokeratoma ablation;
• Ingrown nail treatment;
• Neuromas/fibromas, including Morton's neuroma;
• Debridement of ulcers;
• Other soft tissue lesions.

Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.

Otolaryngology (ENT) | | excision of soft tissue for the creation of recipient sites for hair transplantation.
Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

**Podiatry**
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:
• Verrucae vulgaris/plantar (warts), including paronychial, perifungal, and subungual warts;
• Fungal nail treatment;
• Porokeratoma ablation; | |

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Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
• Choanal atresia,
• Leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue;
• Nasal obstruction;
• Adult and juvenile papillomatosis polyps;
• Polypectomy of nose and nasal passages;
• Lymphangioma removal;
• Removal of vocal cord/fold nodules, polyps and cysts;
• Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including | | • Ingrown nail treatment;
• Neuromas/fibromas, including Morton's neuroma;
• Debridement of ulcers;
• Other soft tissue lesions.

Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.

**Otolaryngology (ENT)**
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
• Choanal atresia,
• Leukoplakia, including oral, larynx, uvula, palatal, upper lateral | |

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Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structure and tissueZenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophageal diverticulectomy (ELAED)];Stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil | | pharyngeal tissue;Nasal obstruction;Adult and juvenile papillomatosis polyps;Polypectomy of nose and nasal passages;Lymphangioma removal;Removal of vocal cord/fold nodules, polyps and cysts;Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords; | |

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Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | ablation/tonsillotomy;• Pulmonary bronchial and tracheal lesion removal;• Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial);• Benign and malignant lesions and fibromas (nose and nasal passages);• Benign and malignant tumors and fibromas; (oral);• Stapedotomy/stapedectomy;• Acoustic neuroma in the ear;• Superficial lesions of the ear, including | | • Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structure and tissue• Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophageal diverticulectomy (ELAED)];• Stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy;• Pulmonary bronchial and | |
| | tonsillectomy;• Pulmonary bronchitis and tracheal lesion removal;• Benign and malignant bronchioles; (oral);• Stapedotomy/stapedectomy;• Acoustic neuroma in the ear;• Superficial bronchioles of the ear, including | | tonsillectomy;• Pulmonary bronchioles;• Stapedotomy/stapedectomy;• Acoustic neuroma in the ear;• Pulmonary bronchioles;• Pulmonary bronchioles;• Pulmonary bronchioles;• Pulmonary bronchioles;• Pulmonary bronchioles;• Pulmonary bronchioles;• Pulmonary bronchioles;• Pulmonary bronchioles;• Pulmonary bronchioles;• Pulmonary bronchioles;• Pulmonary bronchioles;• Pulmonary bronchioles;• Pulmonary bronchioles;• Pulmonary bronchioles;• Pulmonary bronchioles; | |

{27}

Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | chondrodermatitis
nondularis
chronica
helices/Winkler’s
disease;
• Telangiectasia/he
mangioma of
larynx, pharynx
and trachea
(includes uvula,
palatal or upper
lateral pharyngeal
tissue);
• Cordectomy,
cordotomy (for the
treatment of vocal
fold
paralysis/vocal
fold motion
impairment), and
cordal lesions of
larynx, pharynx
and trachea;
• Myringotomy/tym
panostomy
(tympanic
membrane
fenestration); | | tracheal lesion
removal;
• Benign and
malignant
nodules, tumors
and fibromas
(larynx,
pharynx,
trachea,
tracheobronchial
/endobronchial);
• Benign and
malignant
lesions and
fibromas (nose
and nasal
passages);
• Benign and
malignant
tumors and
fibromas; (oral);
• Stapedotomy/stapedectomy;
• Acoustic
neuroma in the
ear;
• Superficial
lesions of the
ear, including
chondrodermatit | |

{28}

Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | • Uvulopalatoplasty (LAUP, laser UPPP);
• Turbinectomy and turbinate reduction/ablation );
• Septal spur ablation/reduction and septoplasty;
• Partial glossectomy;
• Tumor resection on oral, subfascial and neck tissues;
• Rhinophyma;
• Verrucae vulgaris (warts);
• Gingivoplasty/gin givectomy.

**Gynecology (GYN)**
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
• Conization of the cervix, including cervical | | is nondularis chronica helices/Winkler’s disease;
• Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue);
• Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea;
• Myringotomy/tympanostomy (tympanic membrane fenestration); | |

{29}

Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
• Condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen’s disease, (Erythroplasia of Queyrat) and Bowenoid papulosis (BP) lesions;
• Leukoplakia (vulvar dystrophies);
• Incision and drainage (I&D) of Bartholin’s and Nabothian cysts;
• Herpes vaporization;
• Urethral caruncle vaporization;
• Cervical dysplasia; | | • Uvulopalatoplasty (LAUP, laser UPPP);
• Turbinectomy and turbinate reduction/ablation;
• Septal spur ablation/reduction and septoplasty;
• Partial glossectomy;
• Tumor resection on oral, subfascial and neck tissues;
• Rhinophyma;
• Verrucae vulgaris (warts);
• Gingivoplasty/gingivectomy.

**Gynecology (GYN)**
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of: | |

{30}

Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | • Benign and malignant tumors;
• Hemangiomas.

GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:
• Endometrial lesions, including ablation of endometriosis;
• Excision/lysis of adhesions;
• Salpingostomy
• Oophorectomy/ov ariectomy;
• Fimbrioplasty;
• Metroplasty;
• Microsurgery (tubal);
• Uterine myomas and fibroids;
• Ovarian fibromas and follicle cysts; | | • Conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
• Condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen’s disease, (Erythroplasia of Queyrat) and Bowenoid papulosis (BP) lesions;
• Leukoplakia (vulvar dystrophies);
• Incision and drainage (I&D) of Bartholin’s | |

{31}

Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | • Uterosacral ligament ablation;
• Hysterectomy.

**Neurosurgery**
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:
Cranial
• Posterior fossa tumors;
• Peripheral neurectomy;
• Benign and malignant tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors);
• Arteriovenous malformation;
• Pituitary gland tumors (transsphenoidal approach). | | and Nabothian cysts;
• Herpes vaporization;
• Urethral caruncle vaporization;
• Cervical dysplasia;
• Benign and malignant tumors;
• Hemangiomas.

**GYN Laparoscopy**
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:
• Endometrial lesions, including ablation of endometriosis;
• Excision/lysis of adhesions;
• Salpingostomy | |

{32}

Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | Spinal Cord
• Incision/excision and vaporization of benign and malignant tumors and cysts;
• Intra- and extradural lesions;
• Laminectomy/ laminotomy/ microdiscectomy.

Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:
Arthroscopy
• Meniscectomy;
• Chondromalacia;
• Chondroplasty;
• Ligament release (lateral and other);
• Excision of plica;
• Partial synovectomy.

General
• Debridement of traumatic wounds; | | • Oophorectomy/ ovariectomy;
• Fimbrioplasty;
• Metroplasty;
• Microsurgery (tubal);
• Uterine myomas and fibroids;
• Ovarian fibromas and follicle cysts;
• Uterosacral ligament ablation;
• Hysterectomy.

Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of: Cranial
• Posterior fossa tumors;
• Peripheral neurectomy;
• Benign and malignant tumors and cysts (e.g. gliomas, | |

{33}

Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | • Debridement of decubitus and diabetic ulcers;
• Microsurgery;
• Artificial joint revision;
• PMMA removal.

**General/Thoracic Surgery**
Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:
• Debridement of decubitus ulcers, stasis, diabetic and other ulcers;
• Mastectomy;
• Debridement of burns;
• Rectal and anal hemorrhoidectomy;
• Breast biopsy;
• Reduction mammoplasty; | | meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors);
• Arteriovenous malformation;
• Pituitary gland tumors (transsphenoidal approach).

**Spinal Cord**
• Incision/excision and vaporization of benign and malignant tumors and cysts;
• Intra- and extradural lesions;
• Laminectomy/laminotomy/microdiscectomy.

**Orthopedics**
Incision/excision and | |

{34}

Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | • Cytoreduction for metastatic disease;
• Laparotomy and laparoscopic applications;
• Mediastinal and thoracic lesions and abnormalities;
• Skin tag vaporization;
• Atheroma;
• Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips;
• Pilonidal cyst removal and repair;
• Abscesses;
• Other soft tissue applications.

**Dental/Oral Surgery**
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: | | vaporization and of soft tissue in orthopedic surgery. Applications include:
Arthroscopy
• Meniscectomy;
• Chondromalacia;
• Chondroplasty;
• Ligament release (lateral and other);
• Excision of plica;
• Partial synovectomy.

**General**
• Debridement of traumatic wounds;
• Debridement of decubitus and diabetic ulcers;
• Microsurgery;
• Artificial joint revision;
• PMMA removal.

**General/Thoracic Surgery** | |

{35}

Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | • Gingivectomy-removal of hyperplasia;
• Gingivoplasty;
• Incisional and excisional biopsy;
• Treatment of ulcerous lesions, including aphthous ulcers;
• Incision of infection when used with antibiotic therapy;
• Frenectomy (frenum release);
• Excision and ablation of benign and malignant lesions;
• Homeostasis;
• Operculectomy;
• Crown lengthening;
• Removal of soft tissue, cysts and tumors;
• Oral cavity tumors and hemangiomas;
• Abscesses; | | Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures.
Applications include:
• Debridement of decubitus ulcers, stasis, diabetic and other ulcers;
• Mastectomy;
• Debridement of burns;
• Rectal and anal hemorrhoidectomy;
• Breast biopsy;
• Reduction mammoplasty;
• Cytoreduction for metastatic disease;
• Laparotomy and laparoscopic applications;
• Mediastinal and thoracic lesions and abnormalities; | |

{36}

Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | • Extraction site hemostasis;
• Salivary gland pathologies;
• Pre-prosthetic gum preparation;
• Leukoplakia;
• Partial glossectomy;
• Periodontal gum resection.

**Genitourinary**
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:
• Benign and malignant lesions of external genitalia;
• Condyloma;
• Phimosis
• Erythroplasia

**ProScan The Alma Hybrid ProScan CO2** fractional applicator, with wavelength of 10600 nm is indicated for: • Laser | | • Skin tag vaporization;
• Atheroma;
• Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips;
• Pilonidal cyst removal and repair;
• Abscesses;
• Other soft tissue applications.

**Dental/Oral Surgery**
Incision/excision and vaporization of soft tissue in dentistry and oral surgery.
Applications include:
• Gingivectomy-removal of hyperplasia;
• Gingivoplasty;
• Incisional and excisional biopsy;
• Treatment of ulcerous lesions, | |

{37}

Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | skin resurfacing (ablation and/or vaporization) of soft tissue The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: • Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue. | | including aphthous ulcers;
• Incision of infection when used with antibiotic therapy;
• Frenectomy (frenum release);
• Excision and ablation of benign and malignant lesions;
• Homeostasis;
• Operculectomy;
• Crown lengthening;
• Removal of soft tissue, cysts and tumors;
• Oral cavity tumors and hemangiomas;
• Abscesses;
• Extraction site hemostasis;
• Salivary gland pathologies; | |

{38}

Special 510(k) Summary

| Parameter | Subject Device | Primary Predicate | Reference Predicate | Similarities / Differences |
| --- | --- | --- | --- | --- |
| | | | • Pre-prosthetic gum preparation;
• Leukoplakia;
• Partial glossectomy;
• Periodontal gum resection.

**Genitourinary**
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:
• Benign and malignant lesions of external genitalia;
• Condyloma;
• Phimosis
• Erythroplasia | |

VI. Summary of technological characteristics of the device compared to the predicates [21 CFR 807.92(a)(6)]

The technical characteristics for the Alma Hybrid Laser System are substantially equivalent to the K203441 and K103501 devices.

{39}

Special 510(k) Summary

# VII. Performance Testing [21 CFR 807.92(b)(1)]- Performed under K230441

IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for safety
IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance – Electromagnetic Compatibility
IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1 Safety of laser products-Part 1: Equipment Classification, requirements and user’s guide
ISO 10993-1 Biological evaluation of medical devices -- Part 1
ISO 17665-1 Sterilization of health care products – moist heat
IEC 62304 Medical Device Software
ISO 14971 Risk Analysis

Premarket Notification, Special 510(k) Alma Hybrid Laser System
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Special 510(k) Summary

## VIII. Clinical Data [21 CFR 807.92(b) (2)]

Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no human clinical studies were deemed needed to support this submission.

## IX. Conclusions Safety and Effectiveness SE [21 CFR 807.92(b) (3)]

The Alma Hybrid Laser System is as safe and effective as the predicate devices. The proposed Alma Hybrid Laser System has the same intended use and indications as the predicate with proposed expanded indications, similar technological characteristics, and the same principles of operation as its predicate devices. Thus, the Alma Hybrid Laser System is substantially equivalent to its predicate.

## Summary of Supporting Data:

A risk assessment and supporting documentation demonstrate that the change does not affect the safety and effectiveness of the device. No new testing is required beyond what was included in the previously cleared submission.

## Conclusion:

The modified device, incorporating the new indication for use, remains substantially equivalent to the previously cleared version under Original 510(k) K230441

Premarket Notification, Special 510(k) Alma Hybrid Laser System
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