Who is the manufacturer of Alma Harmony?

Alma Lasers, Inc. filed the 510(k) submission for Alma Harmony (K233024).

What is the FDA product code for Alma Harmony?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Alma Harmony?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Alma Harmony?

Alma Harmony (K230308); Hybrid ProScan/HyLight (K203441); Er:YAG Laser Module (K072564); Alma Q (K170850).

Who can help prepare an FDA 510(k) submission like Alma Harmony?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Alma Harmony

K233024 · Alma Lasers, Inc. · GEX · Feb 8, 2024 · General, Plastic Surgery

Device Facts

Record ID	K233024
Device Name	Alma Harmony
Applicant	Alma Lasers, Inc.
Product Code	GEX · General, Plastic Surgery
Decision Date	Feb 8, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Alma Harmony 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).

Device Story

Alma Harmony is a multi-technology platform for dermatologic, aesthetic, and pain management procedures. System comprises a microprocessor-controlled console housing power supply, electronics, and user interface, supporting 10 interchangeable applicators (laser, IPL, NIR). Operates by delivering energy (laser, light, or infrared) to skin surface to induce photothermolysis, ablation, vaporization, or coagulation. Used in clinics by physicians/trained practitioners. Output parameters (wavelength, fluence, pulse width) are controlled via interface. Clinical benefit includes tissue remodeling, lesion removal, and pain relief. Includes Smart Clinic software for data management. Healthcare providers use output to perform targeted tissue treatments; device provides therapeutic effects through controlled energy delivery.

Clinical Evidence

No human clinical studies were performed. Evidence consists of bench testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, ISO 10993-1), software verification/validation, and chronic porcine histology studies for the ClearSkin Pro 1540nm and SupErb 2940nm applicators, confirming healing profiles.

Technological Characteristics

Multi-platform system using laser (Er:YAG, Nd:YAG, Diode), IPL (AFT), and NIR energy. Features contact cooling on select applicators. Connectivity includes Smart Clinic software. Software is microprocessor-controlled. Sterilization: non-sterile (applicators cleaned/disinfected per instructions).

Indications for Use

Indicated for dermatological, aesthetic, and surgical procedures including skin resurfacing, treatment of wrinkles, vascular/pigmented lesions, hair removal, acne, and soft tissue surgery. Applicable to all skin types (Fitzpatrick I-VI) depending on the specific applicator used. Contraindications are not explicitly listed, but use is restricted to professional medical settings.

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 Harmony (K230308)
Hybrid ProScan/HyLight (K203441)
Er:YAG Laser Module (K072564)
Alma Q (K170850)

Reference Devices

Wontech (K231054)
Soprano Titanium (K210371)

Related Devices

K230308 — Alma Harmony · Alma Lasers, Inc. · Mar 1, 2023
K103664 — PRIMUS AESTHETIC PLATFORM · Palomar Medical Technologies, Inc. · Mar 17, 2011
K112505 — ETHEREA · Regulatory Insight, Inc. · Apr 6, 2012
K072564 — ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM · Alma Lasers , Ltd. · May 23, 2008
K110907 — PALOMAR ICON (TM) AESTHETIC SYSTEM · Palomar Medical Technologies, Inc. · Jun 22, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 8, 2024 Alma Lasers, Inc. Jessica Rivera-Montejo Director - Regulatory Affairs and Quality 485 Half Day Road #100 Buffalo Grove, Illinois 60089 Re: K233024 Trade/Device Name: Alma Harmony 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, ILY, ONF, OUG Dated: September 22, 2023 Received: September 22, 2023 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. {1}------------------------------------------------ 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 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-reportingcombination-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. 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). {2}------------------------------------------------ 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/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Tanisha L. Hithe Tanisha L. s 2024.02.08 Hithe -S 13:44:30 -05'00' 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233024 Device Name Alma Harmony #### Indications for Use (Describe) Intended Use: The Alma Harmony is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). #### Clear Skin Pro 1540nm Applicator: The ClearSkin Pro 1540nm is indicated for : Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. #### SupErb 2940nm Applicator: The 2940 nm Er.Y AG Laser Module handard and scanner accessory tips (with and without contactcooling) is indicated for use in soft tissue (skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. Dermatology and Plastic Surgery: Skin resurfacing, Treatment of wrinkles, Epidermal nevi, Telangiectasia, Spider veins, Actinic chelitis, Keloids, Verrucae, Skin tags, keratoses, Scar revision (including acne scars), Debulking benign tumors, Debulking cysts, Superficial skin lesions, Diagnostic biopsies, Decubitus ulcers. General Surgery: Surgical incision, vaporization, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated. Genitourinary: Treatment of: Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar, lesions, polyps, and familiar polyps of the colon. Gynecology: Treatment of: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma. Oral/Maxiofacial: Treatment of: Benign oral tumors, oral and glossal lesions, and gingivectomy. Otothrynolaringology / Head and Neck (ENT): Treatment of: Ear, nose and throat lesions, polyns, cysts, hyperkeratosis, Excision of carcinogenic tissue and oral leukoplakia. Ophthalmology : Treatment of: Soft tissue surrounding the eye and orbit. Podiatry: Treatment of: Warts, plantar verrucae, large mosaic verrucae, Matrixectomy. Clear Lift Pro Q-Switched Cr: Nd: YAG 1064 / 532 nm Applicator 1064mm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks. {4}------------------------------------------------ 532 nm mode is indicated for tattoo removal including red, blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, spider nevi and the treatment of benign pigmented lesions including Café-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532mm mode is also indicated for incision, ablation and vaporization of soft tissue in general dermatology. ## ClearVas Nd:YAG 1064nm For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stams, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins. Treatment of wrinkles. Removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB). The ClearVas Nd: YAG 1064nm is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. # Iris VL / PL Applicator: Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI). Iris Dye VL / Dye SVL Applicator: The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V). ### Iris SHR Applicator: The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin ### Iris Acne Applicator: Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology. The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for: The treatment of moderate inflammatory acne vulgaris. FORM FDA 3881 (6/20) {5}------------------------------------------------ The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). The treatment of cutaneous lesions including warts, scars and striae. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations. Use on all skin types (Fitzpatrick I-VI). Iris NIR Applicator: Intended to emit energy in the infra-red spectrum to provide topical heating for the purpose of elevating the tissue temperature. For the temporary relief of minor muscle pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain. Iris Diode Applicator The Iris diode is intended for use for vascular lesions, spider naevi, teleangiectass, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | | | |X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {6}------------------------------------------------ #### Section 7 510(k) Summary Alma Harmony K233024 A summary of 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 | 485 Half Day Rd. Suite 100 Buffalo Grove, IL 60089 | | Contact Person | Jessica Rivera-Montejo 224-377-2000- phone Jessica.rivera-montejo@almalasers.com | | Summary Preparation Date | February 4, 2024 | #### II. Name of device [21 CFR 807.92 (a) (2)] | Common Device Name(s) and Regulatory Class | Product Code(s) | Classification Panel | Regulation | |----------------------------------------------------------------------------------------------------|--------------------|---------------------------------------|-------------------| | Laser Surgical Instrument for use in general and plastic surgery and in dermatology Class II | GEX | General & Plastic Surgery Panel 79 | § 21 CFR 878.4810 | | Lamp, Infrared Therapeutic Class II | ILY | General & Plastic Surgery Panel 79 | § 21 CFR 890.5500 | | Powered Light Based Non- Laser Surgical Instrument with thermal effect | ONF | General & Plastic Surgery Panel 79 | § 21 CFR 878.4810 | | Medical Device Data System | OUG | General Hospital, Panel 80 | § 21 CFR 880.6310 | #### III. Predicate Device table by Applicator | Applicator | Predicate K Number | Predicate Name | Reference K Number | Reference Name | |-------------------------|-----------------------|------------------------|-----------------------|-------------------| | Iris SHR | K230308 | Alma Harmony | N/A | N/A | | ClearSkin Pro 1540nm | K203441 | Hybrid ProScan 1570 | N/A | N/A | | SupErb 2940nm | K072564 | Er:YAG Laser | N/A | N/A | {7}------------------------------------------------ | Applicator | Predicate K Number | Predicate Name | Reference K Number | Reference Name | |----------------------------------------------|-----------------------|----------------|-----------------------|-------------------| | | | Module | | | | ClearLift Pro Q-Switch (1064nm and 532nm) | K170850 | Alma Q | N/A | N/A | | ClearVas Nd:YAG 1064nm | K170850 | Alma Q | K231054 | Wontech | | Previously cleared applicators | | | | | | Iris VL/PL | K230308 | Alma Harmony | N/A | N/A | | Iris Dye VL / SVL | K230308 | Alma Harmony | | | | Iris Acne | K230308 | Alma Harmony | | | | Iris NIR | K230308 | Alma Harmony | | | | Iris Diode Laser | K230308 | Alma Harmony | | | In addition, this submission will add the Smart Clinic Software. This software was previously cleared in the Alma Titanium K230371. #### IV. Intended use of device and Indications for Use [21 CFR 807.92(a) (5)] #### Intended Use: The Alma Harmony 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). #### Indications for use: #### ClearSkin Pro 1540nm applicator The ClearSkin Pro 1540 nm is indicated for: Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. ### SupErb 2940 nm Applicator The 2940 nm Er:YAG Laser Module handpiece with standard and scanner accessory tips (with and without contact-cooling) is indicated for use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. Dermatology and Plastic Surgery: Skin resurfacing, Treatment of wrinkles, Epidermal nevi, Telangiectasia, Spider veins, Actinic chelitis, Keloids, Verrucae, Skin tags, Anal tags, keratoses, Scar revision (including acne scars), Debulking benign tumors, Debulking cysts, Superficial skin lesions, Diagnostic biopsies, Decubitus ulcers. {8}------------------------------------------------ # K233024 General Surgery: Surgical incision/excision, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated. Genitourinary: Treatment of: Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar. lesions, polyps, and familiar polyps of the colon. Gynecology: Treatment of: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma. Oral/Maxiofacial: Treatment of: Benign oral tumors, oral and glossal lesions, and gingivectomy. Otorhrynolaringology / Head and Neck (ENT): Treatment of: Ear, nose and throat lesions, polyps, cysts, hyperkeratosis, Excision of carcinogenic tissue and oral leukoplakia. Ophthalmology: Treatment of: Soft tissue surrounding the eye and orbit. Podiatry: Treatment of: Warts, plantar verrucae, large mosaic verrucae, Matrixectomy. ### Clear Lift Pro Q-Switched Cr: Nd: YAG 1064 / 532 nm Applicator 1064nm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks. 532 nm mode is indicated for tattoo removal including red, blue and light blue and green inks, for the treatment of benign vascular lesion s including telangiectasias, spider angiomas, cherry angiomas, spider nevi and the treatment of benign pigmented lesions including Café-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532nm mode is also indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology. #### ClearVas Nd: YAG 1064 nm Applicator For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins. Treatment of wrinkles. {9}------------------------------------------------ Removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB). The ClearVas ND:YAG 1064nm is indicated for use on all skin types (Fitzpatrick IVI), including tanned skin. # Iris VL / PL Applicator: Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI). ### Iris Dye VL / Dye SVL Applicator: The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V). ### Iris SHR Applicator: The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin {10}------------------------------------------------ ### Iris Acne Applicator: Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology, The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for: The treatment of moderate inflammatory acne vulgaris The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). The treatment of cutaneous lesions including warts, scars and striae. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I-VI) ### Iris NIR Applicator: Intended to emit energy in the infra-red spectrum to provide topical heating for the purpose of elevating the tissue temperature. For the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain. ### Iris Diode Applicator The Iris diode is intended for use for vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. cafeau-lait stains, lentigo), hemangiomas, port wine stains, rosacea. #### V. Device Description [21 CFR 807.92(a) (4)] The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics, and the user interface. It has 10 applicators that are attached to the console, which can be selected for use in treatment through the user interface. {11}------------------------------------------------ In addition, this submission will add the Smart Clinic Software that was previously cleared in the Soprano Titanium (K210371). #### VI. Summary of technological characteristics of the device compared to the predicate [21 CFR 807.92(a)(6)] The subject Harmony system shares with the predicate devices the same underlying technology and presents nearly identical technological characteristics. Both systems use laser, IPL and Near InfraRed (NIR) energy delivered to the skin surface via applicators. The subject Alma Harmony is substantially equivalent to the previously cleared predicate devices with respect to hardware and software, principle of operation and product design. #### Comparison of the ClearSkin Pro 1540nm and the Hybrid ProScan | Device Trade Name | Subject Device | Predicate Device | Comparison | |------------------------------------------------------------------------------------------|----------------------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ClearSkin Pro | Harmony ClearSkin Pro | Hybrid ProScan/HyLight – K203441 | | | Wavelength (nm) | 1540 nm | 1570 nm | The subject device's wavelength is similar to the predicate and is supported by the histology study. | | Energy range per pulse per microbeam (mJ/Pixel) | | | | | 7x7 | 6-82 mJ/Pixel | 1-144 mJ/Pixel | It is within the predicate range, and it is supported in the histology study. | | Microbeam diameter (Pixel) include pic [mm] | | | | | 7X7 | 1.27mm | 1mm | The proposed device's spot size does not raise new concerns for safety and effectiveness, and it is supported in the histology study. | | Spacing between the micro beam centers [mm] | | | | | 7X7 | 1.33mm | 1.8mm | It is supported in the histology study and does not raise new concerns for safety and effectiveness. | | Pulse Width (milliseconds) | 3 | 0.4-30 | It is within the predicate range, and it is supported in the histology study. | | Pulse Repetition Rate (Hz) | 1-3 | 1-5 | The PR range is within the range of the predicate device. | | Cooling | Yes | Yes | Same | | Device Trade Name | Subject Device | Predicate Device | Comparison | | SupErb | Harmony SupErb | Er:YAG Laser Module K072564 | | | Wavelength (nm) | 2940 nm | 2940 nm | Same | | Energy range per pulse per microbeam (mJ/Pixel) | | | | | 7x7 | 4-73 mJ/Pixel | 4-51 mJ/Pixel | The proposed device's energy range does not raise new concerns for safety and effectiveness, and it is supported in the histology study. | | 7 × 1 | 29-100 mJ/Pixel | 4-51 mJ/Pixel (7x7) | This tip(7x1) is the same as the 7x7 technology. Same tip with one row. The proposed device's energy range does not raise new concerns for safety and effectiveness.. It is supported in the histology study | | Microbeam diameter (Pixel) include pic [mm] | | | | | 7x7 | 0.7mm | 0.7mm | Same | | 7 × 1 | 0.7mm | 0.7mm | Same | | Spacing between the micro beam centers [mm] | | | | | 7x7 | 1.3mm | 1.1mm | Does not raise new concerns for safety and effectiveness. | | 7 × 1 | 1.2mm | 1.3mm | Does not raise new concerns for safety and effectiveness. | | Focus beam diameter (non- Fractional) | 1mm – 6mm | 1mm - 6mm | Same | | Energy range per pulse per Spot Size [mJ/pulse] for the non- Fractional Focus Beam | | | | | 1mm | 200-1400 | 100-1400 | Within the range of the predicate device. | | 2mm | 200-1400 | N/A | The corresponding lower fluence for the 2mm spot size does not raise new concerns regarding safety and effectiveness when compared to the 1mm spot size. | | 3mm | 200-1400 | N/A | The corresponding lower fluence for the 3mm spot size does not | | Device Trade Name | Subject Device | Predicate Device | Comparison | | SupErb | Harmony SupErb | Er:YAG Laser Module K072564 | raise new concerns regarding safety and effectiveness. | | 4mm | 200-1400 | 100-1400 | Within the range of the predicate device. | | 5mm | 200-1400 | N/A | The corresponding lower fluence for the 5mm spot size does not raise new concerns regarding safety and effectiveness. | | 6mm | 200-1400 | N/A | The corresponding lower fluence for the 6mm spot size does not raise new concerns regarding safety and effectiveness. | | 8mm | 100-250 | N/A | The corresponding lower fluence for the 8mm spot size does not raise new concerns regarding safety and effectiveness. | | Pulse Width (ms) | 0.25-1.5 | 1-2 | The proposed device's PW does not raise new concerns for safety and effectiveness | | Pulse Repetition Rate (Hz) | 1mm-6mm: 2-6 8mm: 20 @ 0.18ms | 2,5 | Higher rep rate for subject device is in-motion at a lower fluence. The proposed device's RR does not raise new concerns for safety and effectiveness. | | Cooling | Yes | Yes | Same | {12}------------------------------------------------ # Comparison of the SupErb 2940nm to the Er:YAG Laser Module {13}------------------------------------------------ # Comparison of the ClearLift Pro(532nm) to the Alma Q (532nm) | Device Trade Name | Subject Device | Predicate Device | Comparison | |----------------------------------------------------|-----------------------|------------------|----------------------------------------------------------------------------------------------------------------------------| | ClearLift Pro | Harmony ClearLift Pro | Alma Q K170850 | | | Wavelength (nm) | 532 nm | 532 nm | Same | | Spot Size | 2mm-10mm | 2mm-8mm | The lower fluence for the 9mm and 10mm spot sizes does not raise new concerns regarding safety and effectiveness. | | Energy range per pulse per Spot Size [mJ/pulse] | | | | | 2mm | 400 | 50-450 | | {14}------------------------------------------------ | Device Trade Name | Subject Device | Predicate Device | Comparison | |----------------------------|-----------------------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | ClearLift Pro | Harmony ClearLift Pro | Alma Q K170850 | | | 3mm | 400 | 50-450 | Within predicate range. | | 4mm | 400 | 50-450 | | | 5mm | 400 | 50-450 | | | 6mm | 400 | 50-450 | | | 7mm | 400 | 50-450 | | | 8mm | 400 | 350-700 | | | 9mm | 400 | N/A | Compared to the 2mm-8mm spot sizes, the corresponding lower fluence does not raise new concerns for safety and effectiveness. | | 10mm | 400 | N/A | Compared to the 2mm-8mm spot sizes, the corresponding lower fluence does not raise new concerns for safety and effectiveness. | | Focus beam diameter | 2mm – 10mm | 2mm – 8mm | Compared to the 2mm-8mm spot sizes, the corresponding lower fluence does not raise new concerns for safety and effectiveness. | | Pulse Width (nsec) | 10nsec | 7nsec | Device PW does not raise new concerns for safety and effectiveness. | | Pulse Repetition Rate (Hz) | 1-6 | 1, 2, 5, 10 | It is within the predicate range. | | Cooling | Yes | Yes | Same | # Comparison of the ClearLift Pro (1064nm) | Device Trade Name | Subject Device | Predicate Device | Comparison | |----------------------------------------------------|-----------------------|------------------|---------------------------------------------------------------------------------------------------------------------------| | ClearLift Pro (1064nm) | Harmony ClearLift Pro | Alma Q K170850 | | | Wavelength (nm) | 1064 nm | 1064 nm | Same | | Spot Size (mm) | 2-10mm | 1-8mm | The lower fluence for the 9mm and 10mm spot sizes does not raise new concerns regarding safety and effectiveness | | Energy range per pulse per Spot Size [mJ/pulse] | | | | | 2mm | 400-1600 | 200-2000 | Within predicate range. | {15}------------------------------------------------ | Device Trade Name | Subject Device | Predicate Device | Comparison | |----------------------------|-----------------------|------------------|----------------------------------------------------------------------------------------------------------------------------| | ClearLift Pro (1064nm) | Harmony ClearLift Pro | Alma Q K170850 | | | 3mm | 400-1600 | 200-2000 | | | 4mm | 400-1600 | 200-2000 | | | 5mm | 400-1600 | 200-2000 | | | 6mm | 400-1600 | 200-2000 | | | 7mm | 400-1600 | 200-2000 | | | 8mm | 400-1600 | 200-2000 | | | 9mm | 400-1600 | N/A | The lower fluence for the 9mm and 10mm spot sizes does not raise new concerns regarding safety and effectiveness. | | 10mm | 400-1600 | N/A | The lower fluence for the 9mm and 10mm spot sizes does not raise new concerns regarding safety and effectiveness. | | Focus beam diameter (mm) | 2mm – 10mm | 2mm – 8mm | | | Pulse Width (milliseconds) | 10nsec | 7nsec | The device's PW does not raise new concerns for safety and effectiveness. | | Pulse Repetition Rate (Hz) | 1-6 | 1, 2, 5, 10 | Within the predicate range. | | Cooling | Yes | Yes | Same | # Comparison of the ClearVas to the Alma Q K170850 | | Subject Device | Predicate Device | Reference Device | Comparison | |---------------------------------------------------------|---------------------|---------------------|---------------------|-------------------------------------------------------------| | ClearVas | Harmony ClearVas | Alma Q K170850 | Wontech K231054 | | | Wavelength (nm) | 1064 nm | 1064 nm | 1064 nm | Same | | Spot Size | 2mm-8mm | 3mm-8mm | 2-12mm | Within reference predicate range. | | Fluence range per pulse per Spot Size [J/cm^2] | | | | | | 2mm | 200-500 | N/A | 2-300 | Does not raise new concerns for safety and effectiveness | | 3mm | 200-400 | 80-500 | 2-300 | Within predicate range. | | 4mm | 50-170 | N/A | 2-300 | Within reference predicate range. | | 5mm | 50-170 | 30-180 | 2-300 | Within predicate range. | | 6mm | 50-170 | N/A | 2-300 | Within reference predicate range. | | 7mm | N/A | 14-92 | 2-300 | Subject device does not offer 7mm spot size. | | 8mm | 2-7 | 7-58 | 4-7 | Within reference predicate range, | {16}------------------------------------------------ | | Subject Device | Predicate Device | Reference Device | Comparison | |-------------------------------|---------------------|---------------------|---------------------|-----------------------------------| | ClearVas | Harmony ClearVas | Alma Q K170850 | Wontech K231054 | | | | | | | when use In-Motion. | | Focus beam Diameter (mm) | 2mm – 8mm | 3mm – 8mm | 2mm-12mm | Within reference predicate range. | | Pulse Width (milliseconds) | 0.7-45ms | 0.5 – 60ms | Max. 60 ms | Within range of the predicate. | | Pulse Repetition Rate (Hz) | 1,10 | 1,2,3,5 | Max. 10 Hz | Within reference predicate range. | | Cooling | Yes | Yes | Yes | Same | # Comparison of the Iris SHR to the previously cleared Iris SHR | Device Trade Name | Subject Device | Predicate Device | Comparison | |-----------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------------| | Iris SHR | Harmony Iris SHR 650- 950nm | Iris SHR 650-950nm K230308 | | | Wavelength | 650-950 nm (HR/SHR) | 650-950 nm (HR/SHR) | Same | | Energy Density (Fluence) J/cm² | SHR: 3-7 HR: 5-20 | SHR: 3-7 HR: 5-20 | Same | | Spot Size | 6.4 cm2 | 3 cm2 | The increased spot size does not raise new concerns for safety and effectiveness. | | Pulse Width (ms) | 30,40,50 msec: HR (Stationary) 8 msec: SHR (In-Motion) | 30,40,50 msec: HR (Stationary) 8 msec: SHR (In-Motion) | Same | | Rep Rate (Hz) | 0.5 and 3 | 0.5 and 3 | Same | | Mode | Stationary and In Motion | Stationary and In Motion | Same | | Cooling | Yes | Yes | Same | {17}------------------------------------------------ | Device Trade Name | Current Iris VL / PL -540 nm -950 nm | Previously cleared VL / PL - 540 nm -950 nm | Comparison | |--------------------------------|-----------------------------------------|------------------------------------------------|------------| | Iris VL / PL | Harmony Iris VL / PL | K230308 | | | Wavelength | 540-950nm | 540-950nm | Same | | Energy Density (Fluence) J/cm2 | 5-30 | 5-30 | Same | | Spot Size | 3 cm2 | 3 cm2 | Same | | Pulse Width | 10,12,15 mSec | 10,12,15 mSec | Same | | Rep Rate | 0.67 Hz | 0.67 Hz | Same | | Mode | Stationary | Stationary | Same | | Cooling | Yes | Yes | Same | # Comparison of the Iris VL / PL to the previously cleared VL / PL # Comparison of the Iris Dye VL/SVL to the previously cleared Iris Dye VL / SVL | Device Trade Name | Current Iris Dye VL / Dye SVL 500 nm -600 nm | Previously Cleared Iris Dye VL / Dye SVL 500 nm -600 nm | Comparison | |--------------------------------|----------------------------------------------------------|---------------------------------------------------------------|------------| | Iris Dye VL / Dye SVL | Harmony Iris Dye VL/SVL | K230308 | | | Wavelength | 500-600nm | 500-600nm | Same | | Energy Density (Fluence) J/cm² | Dye VL : 5-15 Dye SVL: 1-4 | Dye VL : 5-15 Dye SVL: 1-4 | Same | | Spot Size | 3 cm2 | 3 cm2 | Same | | Pulse Width (ms) | 10,12,15 | 10,12,15 | Same | | Rep Rate (Hz) | VL – 0.5 SVL – 3 | VL – 0.5 SVL – 3 | Same | | Mode | Stationary | Stationary | Same | | Cooling | Yes | Yes | Same | {18}------------------------------------------------ | Device Trade Name | Current Iris HR Mode 650-950 nm | Previously Cleared HR 650-950 nm | Comparison | |-----------------------------------|------------------------------------|-------------------------------------|------------| | Iris HR Mode 650-950 nm | Harmony Iris HR | K230308 | | | Wavelength | 650-950 nm (HR) | 650-950 nm (HR) | Same | | Energy Density (Fluence) J/cm² | HR: 5-20 | HR: 5-20 | Same | | Spot Size | 6.4 cm2 | 6.4 cm2 | Same | | Pulse Width (ms) | 30,40,50 msec) | 30,40,50 msec) | Same | | Rep Rate (Hz) | 0.5 | 0.5 | Same | | Mode | Stationary | Stationary | Same | | Cooling | Yes | Yes | Same | # Comparison of the Iris HR Mode to the previously cleared Iris HR Mode # Comparison of the Iris Acne to the previously cleared Iris Acne | Device Trade Name | Current Iris Acne 420- 950nm | Previously Cleared Acne 420-950nm | Comparison | |--------------------------------|------------------------------------|--------------------------------------|------------| | Iris Acne 420-950nm | Harmony Iris Diode | K230308 | Same | | Wavelength | 420-950nm | 420-950nm | Same | | Energy Density (Fluence) J/cm² | 5-25 | 5-25 | Same | | Spot Size | 6.4 cm2 | 6.4 cm2 | Same | | Pulse Width (ms) | 30-50msec | 30-50msec | Same | | Rep Rate (Hz) | 1 | 1 | Same | | Mode | Stationary | Stationary | Same | | Cooling | Yes | Yes | Same | Premarket Notification, Traditional 510(k) {19}------------------------------------------------ # Comparison of the Iris NIR to the Previously Cleared Iris NIR | Device Trade Name | Current Iris NIR 1300nm | Previously Cleared NIR 1300nm | Comparison | |-------------------|-----------------------------|----------------------------------|------------| | Iris NIR | Harmony Iris NIR | K230308 | | | Wavelength | 1300nm | 1300nm | Same | | Energy Density | 15w-25w | Up to 25W | Same | | Spot Size | 6.4 cm2 | 6.4 cm2 | Same | | Pulse Width | CW | CW | Same | | Mode | CW Stamping | CW Stamping | Same | | Cooling | Yes | Yes | Same | # Comparison of the Iris Diode Laser to the Previously Cleared Iris Diode Laser | Device Trade Name | Current Iris Diode -520nm | Previously Cleared Iris Diode -520nm | Comparison | |-----------------------------------|------------------------------|-----------------------------------------|------------| | Iris Diode - 532 | Harmony Iris Diode | K230308 | | | Wavelength | 520nm | 520nm | Same | | Energy Density (Fluence) J/cm2 | 16-40 J/cm2 | 16-40 J/cm2 | Same | | Spot Size | 0.5-2mm | 0.5-2mm | Same | | Pulse Width | 1-100ms | 1-100ms | Same | | Rep Rate | 1-10hz | 1-10hz | Same | | Mode | Stamping and Motion | Stamping and Motion | Same | | Cooling | No | No | Same | {20}------------------------------------------------ #### Discussion and summary of technological characteristics: Based on the summary of technological characteristics of the Alma Harmony in comparison to the predicates, the proposed modifications do not raise new types of considerations for safety and effectiveness compared to the predicate devices as seen in the tables above. #### VII. Performance Testing [21 CFR 807.92(b)(1)] The following performance data was provided in support of the substantial equivalence determination: IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance. IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility. IEC 60601-2-22 Test for Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment. ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process. Software verification and validation testing was conducted, and documentation provided as recommended by the FDA's "Guidance for the Content of Premarket Submissions Contained in Medical Devices. Chronic animal studies were performed for the ClearSkin Pro 1540nm applicator. Histology was collected at immediate post 1,3, 7, 14, -day post, and 21-day post treatment on 3 porcine and showed healing at the 21-day point and the SupErb 2940 nm Applicator Histology was collected at immediate post, 1,3, 7day post, and14-day post treatment on 3 porcine and showed healing at the 3-day point. Based on the above performance as documented in this application, the subject device was found to have a safety and effectiveness profile that is similar to the predicate devices. Safety is supported by performance testing as well as the animal study. #### 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 clinical studies were deemed needed to support this submission. {21}------------------------------------------------ #### IX. Conclusions Safety and Effectiveness SE [21 CFR 807.92(b) (3)] The Alma Harmony device that is the subject of this 510k pre-market notification is the same or similar in design, intended use, principles of operation, and technological characteristics, compared to the predicate devices. Differences in the subject devices output parameters do not raise new types of questions with regards to safety and effectiveness, and performance testing and histology data provided in this 510k support that the device can be used safely and effectively for the proposed indications for use. The Alma Harmony device that is the subject of this 510K is considered to be substantially equivalent to the predicate devices.