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.

Device Description

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.

AI/ML Overview

This document is a 510(k) premarket notification for the LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems. It aims to demonstrate substantial equivalence to previously legally marketed devices, rather than establishing acceptance criteria or proving device performance through specific studies in the way an AI/ML device would.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable to this submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document does not define specific "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would be common for AI/ML devices. Instead, the "performance" discussed relates to the device's technical specifications and intended use comparison to predicate devices.

Characteristic	LightScalpel® LS-1005 / LS-2010 (K141658)
Laser Medium	CO2
Wavelength (um)	10.6
Laser Drive Source	RF
Output Power (W)	2-10 / 2-20
Pulsed Power (W)	2-10 / 2-20
Gated PW (ms)	5-500
Gated Rep. Rate (pps)	1 or 2-20
Superpulse (W)	2-5 / 2-10
Superpulse Peak (W)	30 / 60
Beam Delivery System	Flexible Fiber Waveguide
System HxWxD (in)	34x15x15 / 40x15x15
System Weight (lb)	35 / 47
Mobility	4 Wheels & Handle
Intended Use	Incision, Excision, Vaporization, Ablation, and/or Coagulation of Soft Tissue in various specialties
Line Voltage - Nom.	100-240 VAC

The acceptance criteria are implicitly that these specifications meet recognized standards for medical laser devices and are substantially equivalent to predicate devices. The "reported device performance" is the list of technical characteristics as presented in the table.

2. Sample size used for the test set and the data provenance:
Not applicable. This is a medical device (laser system), not an AI/ML diagnostic or predictive algorithm. There is no "test set" in the context of evaluating an AI model with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. See point 2.

4. Adjudication method for the test set:
Not applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is not an AI/ML tool designed to assist human readers. It is a CO2 laser system for surgical procedures.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. See point 5.

7. The type of ground truth used:
Not applicable. In the context of a 510(k) for a physical medical device like a laser, "ground truth" would refer to established engineering and performance standards for laser systems, and comparison to legally marketed predicate devices. The document states: "Each LS-1005 and LS-2010 laser system is tested for electrical safety and output characteristics." These tests would confirm the device's technical specifications against engineering standards.

8. The sample size for the training set:
Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. See point 8.

Summary of Device Equivalence Study (as per the document):

The submission relies on a non-clinical performance data assessment and a technological characteristics comparison to predicate devices to establish substantial equivalence.

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." (The "Bench Testing section" is not provided in the extracted text).
Clinical performance data: "None. Clinical testing was determined to be unnecessary, as the performance parameters are consistent with predicate CO2 laser systems and technology."
The argument for substantial equivalence is based on the devices being equivalent to predicate laser systems in:
- Emission wavelength
- Control parameters
- Relative output power
- Delivery accessories
- Physical size
- Intended Uses

In essence, this is a documentation of a physical medical device's technical specifications and its comparison to similar, already approved devices, rather than a performance evaluation of an AI/ML algorithm.

Summary

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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

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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

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510(k) Number (if known) K141658

Device Name

LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems

Indications for Use (Describe)

Indications for Use:

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.

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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.

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.

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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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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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)
1. 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
1. 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

1. 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

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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

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.

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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).

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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:

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.

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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).

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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.

1. Technological Characteristics Comparison to Predicate Devices
  The technological characteristics comparison to predicate devices is summarized in the following table.

	LS-1005 /LS-2010K141658	LS-1005K123037 K132661	AlmaPixel CO2™K103501	LumenisAcuPulse™K100415	Sharplan15FK971743
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 FiberWaveguide	Flexible FiberWaveguide	Articulated Arm	Articulated Armor WG	ArticulatedArm/WG
System HxWxD (in)	34x15x15 /40x15x15	34x15x15 /40x15x15	52x17x21	47x15x16	4.3x9.4x28.3
System Weight (Ib)	35 / 47	35 / 47	135	108	33
Mobility	4 Wheels &Handle	4 Wheels &Handle	4 Wheels &Handle	4 Wheels &Handle	4 Wheels &Handle
Intended Use	Incision, Excision,Vaporization,Ablation, and/orCoagulation ofSoft Tissue	Incision, Excision,Vaporization,Ablation, and/orCoagulation ofSoft Tissue	Incision, Excision,Vaporization,Ablation, and/orCoagulation ofSoft Tissue	Incision, Excision,Vaporization,Ablation, and/orCoagulation ofSoft Tissue	IncisionExcisionVaporizationAblationAnd/orCoagulation ofSoft Tissue
Line Voltage - Nom.	100-240 VAC	100-240 VAC	120/230 VAC	100-240 VAC	100-140 VAC

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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.

1. 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.
1. 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.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.