The LightScalpel LS-10 CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, oral surgery, otorhinolaryngology, plastic & reconstructive surgery, podiatry, and urology.

Device Description

The LightScalpel LS-10 laser system is a mobile platform 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 Watts Continuous Wave (CW). Laser energy is conducted to the point of application by a flexible fiber wavequide 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

The provided document is a 510(k) Summary for the LightScalpel LS-10 CO2 Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the context typically seen for AI/ML medical devices.

The information primarily describes the device, its intended use, and a comparison of its technological characteristics to predicate devices. It does not contain the specific type of acceptance criteria and performance study details usually associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC, etc.).

Here's an attempt to extract relevant information based on the prompt, acknowledging the limitations of the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the "acceptance criteria" appear to be defined by showing similar technological characteristics and performance to predicate devices and compliance with relevant safety and performance standards. The "reported device performance" is essentially the LightScalpel LS-10's specifications and features.

Acceptance Criteria (Inferred from Predicate Equivalence)	LightScalpel LS-10 Reported Performance
Technological Characteristics:
Laser Medium: CO2	CO2
Wavelength: 10.6 µm	10.6 µm
Laser Drive Source: RF/DC	RF
Output Power (CW Power): Range	2 - 10 Watts
Pulsed Power: Range	2 - 10 Watts
Gated Pulse Widths: Range	5 - 500 msec
Gated Repetition Rate: Range	1 or 2 - 20 pps
Superpulse Power (avg.): Range	2 - 5 Watts
Superpulse Peak Power: Range	30 Watts
Beam Delivery System: Flexible Fiber Waveguide / Articulated Arm	Flexible Fiber Waveguide
System Dimensions (HxWxD): Comparison	34" x 15" x 15" (~ similar to predicate ranges)
System Weight: Comparison	~~35 lbs (~~ similar to predicate ranges)
Mobility: 4 Wheels & Handle	4 Wheels & Handle
Electrical Power: 115 VAC	115 VAC
Intended Use: Incision, Excision, Vaporization, Ablation, or Coagulation of Soft Tissue	Incision, Excision, Vaporization, Ablation, or Coagulation of Soft Tissue
Safety and Performance Standards Compliance:
21 CFR 1040, Performance Standards for Light-emitting Products	Verified (stated in 510(k) Summary)
IEC 60601-1, Medical Electrical Equipment Part 1	Verified (stated in 510(k) Summary)
IEC 60601-2-22, Medical electrical equipment Part 2-22	Verified (stated in 510(k) Summary)
IEC 60825-1, Safety of laser products Part 1	Verified (stated in 510(k) Summary)

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "Device performance evaluation did not involve Animal or Clinical Testing." This indicates there was no "test set" in the traditional sense of patient or sample data for evaluating clinical performance. The evaluation was based on verification and validation tests per product requirements and specifications, and inspections and tests derived from applicable regulations and safety standards. Details on the specific "sample size" of components tested or the nature of these verification/validation tests are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable, as no animal or clinical testing was conducted. The "ground truth" for demonstrating equivalence was based on meeting established engineering specifications and compliance with international standards, which would be assessed by engineers and regulatory experts, not clinical experts establishing ground truth for a medical image or diagnostic output.

4. Adjudication Method for the Test Set:

Not applicable, as no animal or clinical testing was conducted that would require an adjudication method by expert reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC study was not done. The device is a CO2 laser system, not an AI/ML diagnostic or assistive tool that would typically be evaluated with MRMC studies for human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

The concept of "standalone performance" as it relates to AI algorithms is not applicable here. The device is a surgical instrument. Its "performance" is inherent in its physical operation (e.g., power output, wavelength, safety features) and its ability to achieve the intended surgical effects when operated by a clinician.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to engineering specifications, safety standards, and the established performance characteristics of the predicate devices. For instance, the stated power output (2-10 Watts CW) is verifiable through direct measurement, representing its "ground truth" for that parameter. Compliance with standards like IEC 60601-2-22 serves as a "ground truth" for safety and essential performance requirements.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that undergoes "training." The device is a manufactured hardware system.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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K123037 1/4

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LightScalpel LLC 16932 Woodinville-Redmond Rd NE, Suite 206 Woodinville. WA 98072 PH: 425-368-1588 FAX: 425-483-6015

SECTION 5 - 510(k) Summary

NOV 2 9 2012

510(k) Summary Preparation Date:

1. 510(K) Owner:
  Light Scalpel LLC 16932 Woodinville-Redmond Road NE, Suite 206 Woodinville, WA 98072 866-697-7548 / 425-368-1588 / 425-483-6015 (FAX)
1. 510(k) Contact:
  David Walters General Manager 16932 Woodinville-Redmond Road NE, Suite 206 Woodinville, WA 98072 866-697-7548 / 425-368-1588 / 425-483-6015 (FAX) dwalters@lightscalpel.com
1. Device Trade Name: LightScalpel LS-10
  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)
  The LightScalpel CO2 Laser System is equivalent in operating principles and intended uses to the Luxar LX-20SP and DEKA SmartXide CO2 Laser Systems.
1. Device Description and Function
  The LightScalpel LS-10 laser system is a mobile platform 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 Watts Continuous Wave (CW). Laser energy is conducted to the point of application by a flexible fiber wavequide 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.

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Image /page/1/Picture/1 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 from the bottom left of the image, where it is depicted as a starburst. The rest of the word "Scalpel" is in a regular font.

LightScalpel LLC 16932 Woodinville-Redmond Rd NE, Suite 206 Woodinville, WA 98072 PH: 425-368-1588 FAX: 425-483-6015

A "calibration port" on the side of the laser system allows checking and setting the power emitted from the distal laser aperture and serves as a check on fiber waveguide transmission efficiency. Laser system power, rates, and durations are adjustable as tabulated below:

Parameter	LightScalpel LS-10
CW Power (watts)	2 - 10
Pulsed Power (watts)	2 - 10
Gated Pulse Width (msec)	5 - 500
Gated Rep Rate (pps)	1 or 2 - 20
Single Pulse Energy (mJ)	10 - 5000
Superpulse Power (watts-avg.)	2 - 5
Gated Pulse Widths (msec)	10 - 500
Superpulse Pulse Rates (pps)	160 - 375
Gated Rep Rate (pps)	1 or 2 - 30
Superpulse Peak Power (watts)	30
Superpulse Pulse Width (usec)	100 - 800

The laser system has safety features complying with requirements in 21 CFR 1040, Performance Standards for Light Emitting Products; IEC 60601-2-22, Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment ; and IEC 60825-1, Safety of laser products –Part 1: Equipment classification and requirements. Major 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.

The laser system, components, and features are illustrated in Figure 1. Laser system physical characteristics are:

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Image /page/2/Picture/1 description: The image shows the words "light Scalpel" in a stylized font. The word "light" is in bold, and the "S" in "Scalpel" is connected to the "t" in "light" with a curved line. There is a star-like symbol below the word "light."

LightScalpel LLC 16932 Woodinville-Redmond Rd NE, Suite 206 Woodinville, WA 98072 PH: 425-368-1588 FAX: 425-483-6015

Parameter	LightScalpel LS-10
Dimensions	34" H x 15" W x 15" D
Weight (Pounds / Kg)	~ 35 / ~ 16
Electrical Power	115 VAC, 7.5 A, 50/60 Hz

Delivery System: Flexible Fiber Waveguide; ~ 0.7mm ID.; Handpiece w/internal focusing lens.

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.

1. Intended use(s) of the Device
  The LightScalpel CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, oral surgery, otorhinolaryngology, plastic & reconstructive surgery, podiatry, and urology.
1. Technological Characteristics Comparison to Predicate Devices
  The technological characteristics comparison to predicate devices is summarized in the following table.

Characteristic	LightScalpel	Luxar LX-20 SP	DEKA SmartXide
Predicate 510(k)	N/A	K953074	K072159
Laser Medium	CO2	CO2	CO2
Wavelength (µm)	10.6	10.6	10.6
Laser Drive Source	RF	RF	DC
Output Power (W)	2 - 10	2 - 20	2 - 30
Pulsed Power (W)	2 - 10	2 - 20	0.5 - 15
Gated PW (ms)	5 - 500	5 - 500	0.2 - 80
Gated Rep. Rate (pps)	1 or 2 - 20	2 - 20	5 - 100
Super Pulse (W)	2 - 5	2 - 10	0.5 - 10

K123037_Sec5_Sum2

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LightScalpel LLC 16932 Woodinville-Redmond Rd NE, Suite 206 Woodinville, WA 98072 PH: 425-368-1588 FAX: 425-483-6015

Superpulse Peak (W)	30	50	320
Beam Delivery System	Flexible FiberWaveguide	Articulated Arm orFlexible FiberWaveguide	Articulated Arm
System HxWxD (in)	34 x 15 x 15	36 x 14 x 14	47 x 19 x 22
System Weight (lb)	35	42	66
Mobility	4 Wheels & Handle	4 Wheels & Handle	4 Wheels & Handle
Electrical Power	115 VAC	115 VAC	115 VAC
Intended Use	Incision, Excision,Vaporization,Ablation, orCoagulation of SoftTissue	Incision, Excision,Vaporization,Ablation or,Coagulation of SoftTissue	Incision, Excision,Vaporization,Ablation, orCoagulation of SoftTissue

8. Performance Testing

The LightScalpel LS-10 CO2 Laser System has been evaluated for performance equivalent to predicate devices through a combination of (1) verification and validation tests per product requirements and specifications and (2) inspections and tests derived from applicable regulations and safety standards as noted below.

21 CFR 1040, Performance Standards for Light-emitting Products
IEC 60601-1, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-2-22. Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1, Safety of laser products Part 1: Equipment classification, requirements and user's guide
1. Animal and Clinical Testing

Device performance evaluation did not involve Animal of Clinical Testing.

1. A comparison between the LS-10 and the predicated carbon dioxide lasers showed that these devices have similar laser characteristics and output parameters and therefore a determination of equivalence can be made between the predicate devices and the LS-10.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

LightScalpel, LLC % Mr. David Walters General Manager 16932 Woodinville Redmond Road Northeast Suite 206 Woodinville, Washington 98072

November 29, 2012

Re: K123037

Trade/Device Name: LightScalpel LS-10 CO2 Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: October 30, 2012 Received: October 31, 2012

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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Page 2 - Mr. David Walters

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4 - Indications for Use

510(k) Number (if known): K123037

Device Name: LightScalpel LS-10 CQ2 Laser System

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Neil R Ogden 2012.11.29 10:42:22 -05'00'

(Division Sign-off) Division of Surgical Devices 510(k) Number

LS_Sec4_Ind_510(k)

Section 4 Page 1 of 1

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.