LIGHT SCALPEL

K141658 · Lightscalpel, LLC · GEX · Oct 22, 2014 · General, Plastic Surgery

Device Facts

Record IDK141658
Device NameLIGHT SCALPEL
ApplicantLightscalpel, LLC
Product CodeGEX · General, Plastic Surgery
Decision DateOct 22, 2014
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4810
Device ClassClass 2
AttributesTherapeutic

Intended Use

The LightScalpel CO2 Laser Systems are intended for use in laser surgery procedures for incision, excision, vaporization, and/or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, orthopedic surgery, neurosurgery, podiatry, and urology.

Device Story

LightScalpel LS-1005 & LS-2010 are mobile, RF-excited CO2 laser systems emitting 10.6 µm infrared beams. Systems utilize flexible fiber waveguides and handpieces with ceramic tips to deliver laser energy to soft tissue. Operators control power (2-20W), pulse, and superpulse modes via a touch-screen interface. A calibration port allows power verification. Safety features include emergency stops, interlocks, and beam shutters. Used in clinical settings by physicians for surgical procedures (incision, excision, ablation, vaporization, coagulation). The device provides precise tissue interaction, potentially reducing thermal damage and improving surgical outcomes compared to traditional methods.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety and output characteristic verification.

Technological Characteristics

RF-excited CO2 laser; 10.6 µm wavelength; 2-20W output power; flexible fiber waveguide delivery; touch-screen control; air cooling; 100-240 VAC power; complies with 21 CFR 1040 performance standards.

Indications for Use

Indicated for soft tissue incision, excision, ablation, vaporization, and coagulation across various surgical specialties including general, thoracic, plastic, reconstructive, gynecological, dental, oral, ENT, orthopedic, neurosurgical, podiatric, and dermatological procedures. Specific applications include tumor/lesion removal, resurfacing, debridement, and hemostasis.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure with three faces in profile, representing the department's focus on health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. The logo is simple and recognizable, conveying the department's mission and purpose. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 22, 2014 LightScalpel® LLC Mr. David Walters General Manager 16932 Woodinville-Redmond Road Northeast, Suite 107 Woodinville, Washington 98072 Re: K141658 Trade/Device Name: LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems 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 Dated: August 26, 2014 Received: August 28, 2014 Dear Mr. Walters: 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 (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. 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. 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 {1}------------------------------------------------ CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S - Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K141658 Device Name LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems Indications for Use (Describe) Indications for Use: The LightScalpel LS-1005 & LS-2010 CO2 Laser Systems are in laser surgery procedures for incision, excision, vaporization, ablation, and/or coagulation of soft tissue in specialties such as; general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, neurosurgery, podiatry, and urology. #### Gynecology / Genitourinary: Incision, excision, ablation, and/or vaporization of soft tissue for treatment of: Conization of the cervix, including cervical intraepithelial neoplasia and varinal intraepithelial neoplasia; Condyloma, including cervical, genital, vulvar, perineal, and Bowenoid papulosa; leukoplakia (vulvar dystrophies); incision and drainage of Bartholin's and nabothian cysts: herpes vaporization: urethral caruncle vaporization; cervical dysplasia; benign and malignant tumors; hemangiomas; benign and malignant lesions of external genitalia; condyloma; phimosis; erythroplasia. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ 510(k) Number (if known) K141658 Device Name LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems #### Indications for Use (Describe) #### Dermatology / Plastic Surgery: Incision, Excision, Ablation, and Vaporization of soft tissue for treatment of: laser skin resurfacing; laser dermabrasion; laser burn debridement; wrinkles, rhytids, and furrows; keratosis, including actinic and sebortheic keratosis, seborthoecae vulgares, sebortheica; vermillionectomy 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 granuloma, pyogenicum/granuloma telagiectaticum; tattoos; telangiectasias: removal of small skin tumors, including periungual fibromas; superficial pigmented lesions baceous hypertrophy or sebaceous hyperplasia; rhinophyma reduction; cutaneous papilloma (skin tags); milia; debridement of eczematous or infected skin; basal & 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-epitheliomas; xanthelasma palpebrarum; syringoma; complete or partial nairixectomy; benign/malignant vascular/avascular skin lesions; Mohs surgery; lipectomy; verrucae and seborthoecae vulgares, including; paronychial, periungal, and subungual warts; blepharoplasty: and hair transplantation site preparation. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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." VOL_005 Page 2 of 6 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {4}------------------------------------------------ 510(k) Number (if known) K141658 Device Name LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems Indications for Use (Describe) Dental Surgery: Gingivectorny - Removal of hyperplasias; gingivoplasty; papillectorny; vestibuloplasty; epulis; sulcular debridement; removal of soft tissue, cysts, and fibroma (non-malignant tumor, mucosa, tongue); extraction site hemont of ulcerous lesions, including aphthous ulcers; a heat source to activate tooth bleaching materials; Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament to the root surface in the absence of long junctional epithelium). #### Oral Surgery: Frenum release/frenectomy; abscess (drainage); biopsy (incisional & excisional); aphthous ulcers (incision & excision); excision & ablation of lesions, benign & malignant lesions, oral cavity tumors, and hemangiomas; salivary gland pathologies; preprosthetic gum preparation, leukoplakia; partial glossectomy; periodontal gum resection; homeostasis; operculectomy; crown lengthening (soft tissue); incision when used with antibiotic therapy; extraction site hemostasis. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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 {5}------------------------------------------------ 510(k) Number (if known) K141658 #### Device Name LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems #### Indications for Use (Describe) General and Thoracic Surgery: Incision, excision, and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures for: 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 and pilar cysts, and mucous cysts of the lips; pilonidal cyst removal and repair; abscesses; other soft tissue applications. #### Gyn Laparoscopic Surgery: Laser incision, excision, vaporization of soft tissue for treatment of: endometrial lesions, including ablation for endometriosis; excision/lysis of adhesions; salpingotomy; oophorectomy; fimbrioplasty; metroplasty; uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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 {6}------------------------------------------------ 510(k) Number (if known) K141658 Device Name LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems Indications for Use (Describe) Otorhinolaryngology / ENT: Laser incision, excision, ablation, vaporization, and / or photocoagulation of soft tissue in otorhinolaryngology for treatment of: leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue; adult and juvenile papillomatosis polyps; lymphangioma 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; stenosis, including subglottic stenosis; tonsiller tonsillar cryptolysis and neoplasma) and tonsil ablation / tonsillotomy; benign and malignant tumors and fibromas (oral); superficial lesions of the ear, including chondrodermatitis nondularis chronica helices / Winkler's disease; uvulopalatoplasty (LAUP, laser UPPP); turbinectomy and turbinate reduction / ablation; septal spur ablation and septoplasty; partial glossectomy; tumor resection of oral, subfacial, and neck tissues; rhinophyma; verrucae vulgares (warts); gingivoplasty / gingivectomy Podiatry: Laser excision, ablation, and /or vaporization of soft tissue in podiatry for the reduction, removal and/or treatment of: Verrucae vulgares / plantar warts, including paronychial, periungual, and subungual warts; fungal nail treatment; matrixectomy - partial and complete: porokeratornas/fibromas, including Morton's neuroma removal; ingrown toenail treatment; debridement of ulcers; treatment of other soft tissue lesions. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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 {7}------------------------------------------------ 510(k) Number (if known) K141658 Device Name LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems Indications for Use (Describe) Orthopedic Surgery: Laser incision / excision, and /or vaporization of soft tissue in orthopedic surgery. Applications include: meniscectorny; chondromalacia ablation; chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy; debridement of traumatic wounds; debridement of decubitus & diabetic ulcers; and PMMA removal. Neurosurgery: Laser incision / excision, ablation, and /or vaporization of soft tissue in neurosurgery for the treatment of: posterior fossa tumors; peripheral neurectorny; benign and malignant tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors); arteriovenous malformation; and pituitary gland tumors (transphenoidal approach). 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) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, and the "S" in "Scalpel" is stylized as a curved line that extends below the word and ends in a star-like burst. The rest of the word "Scalpel" is in a regular font. There is a registered trademark symbol next to the word "Scalpel". # VOL_006 - 510(k) Summary 510(k) Summary Preparation Date: 17 June 2014 - 1. 510(K) Owner: LightScalpel® LLC 16932 Woodinville-Redmond Road NE, Suite 107 Woodinville, WA 98072 866-697-7548 / 425-368-1588 / 425-368-1568 (FAX) - 2. 510(k) Contact: David Walters General Manager 16932 Woodinville-Redmond Road NE, Suite 107 Woodinville, WA 98072 866-697-7548 / 425-368-1588 / 425-368-1568 (FAX) dwalters@lightscalpel.com - 3. Device Trade Name: LightScalpel® LS-1005 / LS-2010 Common Name: CO2 Laser System Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810). > "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." Classification: Class II Product Code: GEX - 4. Predicate Device(s): - 4.1. LightScalpel LS-1005 CO₂ Laser System; K123037 & K132661 - 4.2. Alma Pixel CO2" Laser System; K103501 - 4.3. Lumenis AcuPulse™ 30/40 ST & 40WG CO2 Laser Systems; K100415 - 4.4. Sharplan 15F CO2 Laser System; K971743 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, and the word "Scalpel" is in a regular font. A curved line starts above the "S" in "Scalpel", goes over the word, and ends in a starburst below the word "light". # 5. Device Description and Function The LightScalpel LS-1005 / LS-2010 laser systems are mobile platforms that utilizes a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 10 and 2 to 20 Watts Continuous Wave (CW) respectively. The systems differ only in the laser tube used, pre-programmed values in the controlling software, which allow higher laser tube drive for the LS-2010 system, and physical height and weight. Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel. A "calibration port" on the side of the laser systems allows checking and setting the power emitted from the distal laser aperture to the internal power meter and serves as a check on fiber wavequide transmission efficiency. Laser system power, rates, and durations are adjustable as tabulated below: The laser systems have safety features complying with requirements in 21 CFR 1040. Performance Standards for Light Emitting Products. Primary safety features are as follows: System On-Off Keyswitch, Emergency Stop Switch, Remote Interlock, Fiber Interlock, Beam Blocking Shutter, Internal Laser Power Detector, RF Power Monitor, and required Laser Safety Labels and Labeling. Laser system physical characteristics are: Delivery System: Flexible Fiber Wavequide: ~ 0.75mm ID:: Handpieces with internal focusing lens ("tipless") and with disposable pre-sterilized ceramic tips. Purge Gas: Internal air pump purge through the Fiber and Handpiece. System Cooling: Air; two thermostatically controlled fans with over-temperature protection. Mobility: 4 wheels and handgrip on console for convenient system positioning. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, and the word "Scalpel" is in a normal font. A curved line starts from the top of the "S" in "Scalpel" and extends down to the bottom left of the logo, where it ends in a star-like shape. # 6. Intended use(s) of the Device The LightScalpel CO2 Laser Systems are intended for use in laser surgery procedures for incision, excision, vaporization, and/or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, orthopedic surgery, neurosurgery, podiatry, and urology. A listing of typical laser surgery procedures in the medical specialties follows: #### Gynecology / Genitourinary: Incision, excision, ablation, and/or vaporization of soft tissue for treatment of:: Conization of the cervix, including cervical intraepithelial neoplasia and vaginal intraepithelial neoplasia; Condyloma, including cervical, genital, vulvar, perineal, and Bowenoid papulosa; leukoplakia (vulvar dystrophies); incision and drainage of Bartholin's and nabothian cysts; herpes vaporization; urethral caruncle vaporization; cervical dysplasia; benign and malignant tumors; hemangiomas;; benign and malignant lesions of external genitalia; condyloma; phimosis; erythoplasia. #### Dermatology / Plastic Surgery: Incision, Excision, Ablation, and Vaporization of soft tissue for performance of or treatment of: laser skin resurfacing; laser dermabrasion; laser burn debridement; wrinkles, rhytids, and furrows; keratosis, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheci wart, and verruca seborrheica; vermillionectomy 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 granuloma, pyogenicum/granuloma telagiectatioum; tatoos; telangiectasias; removal of small skin tumors, including periungual (Koenen) and subunqual fibromas: superficial pigmented lesions: adenosebaceous hypertrophy or sebaceous hyperplasia; rhinophyma reduction; cutaneous papilloma (skin tags); milia; debridement of eczematous or infected skin; basal & squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions: nevi, including spider, epidermal, and protruding; neurofibromas; laser deepitheliazation; tricoepitheliomas; xanthelasma palpebrarum; syringoma; complete or partial nail matrixectomy; benign/malignant vascular skin lesions; Mohs surgery; lipectomy; verrucae and seborrhoecae vulgares, including; paronychial, periungal, and subungual warts; blepharoplasty; and hair transplantation site preparation. #### Dental Surgery: Gingivectomy - Removal of hyperplasias; gingivoplasty; papillectomy; vestibuloplasty; epulis; sulcular debridement; removal of soft tissue, cysts, and fibroma (non-malignant tumor, mucosa, tonque); extraction site hemostasis; treatment of ulcerous lesions, including aphthous ulcers; a heat source to activate tooth bleaching materials; Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium). {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for LightScalpel. The word "light" is in bold, lowercase letters, and the word "Scalpel" is in lowercase letters. A curved line extends from the top of the "S" in "Scalpel" and ends in a starburst shape at the bottom left of the logo. The registered trademark symbol is located to the right of the word "Scalpel". Oral Surgery: Frenum release/frenectomy; abscess (drainage); flap surgery; biopsy (incisional & excisional); aphthous ulcers (incision & excision & ablation of lesions, benign & malignant lesions, oral cavity tumors, and hemangiomas; salivary gland pathologies; preprosthetic gum preparation, leukoplakia; partial glossectomy; periodontal gum resection; homeostasis; operculectomy; crown lengthening (soft tissue); incision of infection when used with antibiotic therapy; extraction site hemostasis. #### General and Thoracic Surgery: Incision, excision, and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures for: 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; midiastinal and thoracic lesions and abnormalities; skin tag vaporization; atheroma; cysts, including sebaceous and pilar cysts, and mucous cysts of the lips; pilonidal cyst removal and repair; abscesses; other soft tissue applications. Gyn Laparoscopic Surgery: Laser incision, excision, vaporization, and photocoagulation of soft tissue for treatment of: endometrial lesions, including ablation for endometriosis; excision/lysis of adhesions; salpingotomy; oophorectomy; fimbrioplasty; metroplasty; uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectorny. #### Otorhinolaryngology / ENT: Laser incision, excision, ablation, vaporization, and / or photocoagulation of soft tissue in otorhinolaryngology for treatment of: leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue; adult and juvenile papillomatosis polyps; lymphangioma removal: removal of recurrent papillomas in the oral cavity, nasal cavity, larvnx, and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue, and vocal cords; stenosis, including subglottic stenosis; tonsillectomy (including tonsilar cryptolysis and neoplasma) and tonsil ablation / tonsillotomy; benign and malignant tumors and fibromas (oral); superficial lesions of the ear, including chondrodermatitis nondularis chronica helices / Winkler's disease; uvulopalatoplasty (LAUP, laser UPPP); turbinectomy and turbinate reduction / ablation; septal spur ablation/reduction and septoplasty; partial glossectorny; tumor resection of oral, subfacial, and neck tissues; rhinophyma; verrucae vulgares (warts); gingivoplasty / gingivectomy ### Podiatry: Laser excision, ablation, and /or vaporization of soft tissue in podiatry for the reduction, removal and/or treatment of: Verrucae vulgares / plantar warts, including paronychial, periungal, and subungual warts; fungal nail treatment; matrixectomy - partial and complete; porokeratoma ablation; neuromas/fibromas, including Morton's neuroma removal; ingrown toenail treatment; debridement of ulcers; treatment of other soft tissue lesions. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, lowercase letters. The word "Scalpel" is in regular font, with the "S" stylized as a curved line that extends below the word and ends in a starburst shape. The trademark symbol is located to the right of the word "Scalpel". Orthopedic Surgery: Laser incision / excision, ablation, and /or vaporization of soft tissue in orthopedic surgery. Applications include: menisectomy; chondromalacia ablation; chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy; debridement of traumatic wounds; debridement of decubitus & diabetic ulcers; and PMMA removal. Neurosurgery: Laser incision / excision, ablation, and /or vaporization of soft tissue in neurosurgery for the treatment of: posterior fossa tumors; peripheral neurectomy; benign and malignant tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lopomas, and large tumors); arteriovenous malformation; and pituitary gland tumors (transphenoidal approach). {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for "lightScalpel". The word "light" is in bold, and the word "Scalpel" is in a regular font. A curved line starts below the word "light" and extends over the word "Scalpel". At the end of the curved line, there is a star-like symbol. - 7. Technological Characteristics Comparison to Predicate Devices The technological characteristics comparison to predicate devices is summarized in the following table. | | LS-1005 /<br>LS-2010<br>K141658 | LS-1005<br>K123037<br>K132661 | Alma<br>Pixel CO2™<br>K103501 | Lumenis<br>AcuPulse™<br>K100415 | Sharplan<br>15F<br>K971743 | |-----------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | Characteristic | -- | -- | -- | -- | -- | | Laser Medium | CO2 | CO2 | CO2 | CO2 | CO2 | | Wavelength (um) | 10.6 | 10.6 | 10.6 | 10.6 | 10.6 | | Laser Drive Source | RF | RF | RF | DC | DC | | Output Power (W) | 2-10 / 2-20 | 2-10 | 70 | 1 - 30 | 1 - 15 | | Pulsed Power (W) | 2-10 / 2-20 | 2-10 | -- | 1 - 25 | N/A | | Gated PW (ms) | 5-500 | 5-500 | 10 - 1000 | 50 - 1000 | 100 - 1000 | | Gated Rep. Rate (pps) | 1 or 2-20 | 1 or 2-20 | 1 - 100 | 1 - 100 | Adj - On/Off | | Superpulse (W) | 2-5 / 2-10 | 2-5 | -- | .5 - 10 | N/A | | Superpulse Peak (W) | 30 / 60 | 30 | -- | N/A | N/A | | Beam Delivery System | Flexible Fiber<br>Waveguide | Flexible Fiber<br>Waveguide | Articulated Arm | Articulated Arm<br>or WG | Articulated<br>Arm/WG | | System HxWxD (in) | 34x15x15 /<br>40x15x15 | 34x15x15 /<br>40x15x15 | 52x17x21 | 47x15x16 | 4.3x9.4x28.3 | | System Weight (Ib) | 35 / 47 | 35 / 47 | 135 | 108 | 33 | | Mobility | 4 Wheels &<br>Handle | 4 Wheels &<br>Handle | 4 Wheels &<br>Handle | 4 Wheels &<br>Handle | 4 Wheels &<br>Handle | | Intended Use | Incision, Excision,<br>Vaporization,<br>Ablation, and/or<br>Coagulation of<br>Soft Tissue | Incision, Excision,<br>Vaporization,<br>Ablation, and/or<br>Coagulation of<br>Soft Tissue | Incision, Excision,<br>Vaporization,<br>Ablation, and/or<br>Coagulation of<br>Soft Tissue | Incision, Excision,<br>Vaporization,<br>Ablation, and/or<br>Coagulation of<br>Soft Tissue | Incision<br>Excision<br>Vaporization<br>Ablation<br>And/or<br>Coagulation of<br>Soft Tissue | | Line Voltage - Nom. | 100-240 VAC | 100-240 VAC | 120/230 VAC | 100-240 VAC | 100-140 VAC | {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, and the "S" in "Scalpel" is stylized with a curved line extending from the top of the "S" over the word "light". There is a star-like symbol below the word "light". The registered trademark symbol is next to the word "Scalpel". The LS-1005 and LS-2010 laser systems are substantially equivalent to the predicate devices in emission wavelength, control parameters, relative output power, delivery accessories, and physical size. - 8. Non-clinical performance data: Each LS-1005 and LS-2010 laser system is tested for electrical safety and output characteristics. Representative data is presented in the Bench Testing section of this report. - 9. Clinical performance data: None. Clinical testing was determined to be unnecessary, as the performance parameters are consistent with predicate CO2 laser systems and technology. - 10.In summary, the LightScalpel LS-1005 and LS-2010 CO2 laser systems are equivalent to the predicate laser systems in technical characteristics and for the intended uses in the stated medical specialties.
Innolitics
510(k) Summary
Decision Summary
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