The Luminex LL System is a non-thermal, non-invasive, low energy infrared laser, therapeutic medical device that is intended for use as an adjunctive treatment for the temporary relief of hand and wrist pain associated with carpal tunnel syndrome. The Luminex Laser Therapy System incorporates an AC or battery powered Control Unit and a hand-held laser diode probe incorporating three 30 milliwatt (mW) Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering a total output power of 90mW at the 830 nanometer (nm) wavelength.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Luminex LL Laser System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing de novo studies with specific acceptance criteria, large sample sizes, and detailed ground truth establishment as would be seen in a PMA (Premarket Approval Application) or clinical trial for a novel device.

Therefore, many of the requested details such as specific acceptance criteria for performance metrics, detailed sample sizes for test/training sets from prospective data, number of experts for ground truth, adjudication methods, MRMC studies, and standalone algorithm performance studies are not applicable (N/A) in this context as they are not typically part of a 510(k) submission for this type of device.

Here's a breakdown based on the available information:

A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices	Demonstrated substantial equivalence to the Microlight Corporation of America, Inc., MicroLight 830 Laser System (K010175), the Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657), and the Meridian Co., Ltd., Lapex 2000 (K034009) based on:
- Same intended uses.	- Intended for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome, matching predicate devices.
- Similar technical and performance characteristics (infrared lamps, invisible photonic energy to tissue).	- Emits invisible photonic energy to tissue using three 30mW Gallium Aluminum Arsenide (GaAlAs) laser diodes (total 90mW) at 830nm wavelength, similar to predicate devices. Classified as an infrared lamp per 21 CFR 890.5500.
Functional Performance and Electrical Safety Compliance	- System underwent functional performance testing and electrical safety testing.
Compliance with FDA's Quality System Regulations and applicable standards for light-emitting medical devices.	- Manufactured to comply with FDA's Quality System Regulations and applicable standards for light emitting medical devices.
Does not raise new questions of safety or effectiveness.	- Conclusion states the Luminex LL Laser System performs as intended and does not raise any new questions of safety or effectiveness when compared to predicate devices. It is designed to comply with generally accepted therapeutic laser performance specifications as an adjunctive treatment for relief of hand and wrist pain associated with Carpal Tunnel Syndrome. FDA's letter concurs with substantial equivalence.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This submission relies on demonstrating substantial equivalence to predicate devices, not on a clinical test set with human subjects to evaluate efficacy against specific metrics for the device itself. The "testing" mentioned is functional performance and electrical safety testing of the device hardware, not a clinical study on patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. No clinical "test set" and corresponding ground truth determination by experts are described for this 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No clinical "test set" requiring adjudication is described.
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
- N/A. This device is a therapeutic laser, not an AI-powered diagnostic imaging device. No MRMC studies were conducted or are relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a hardware therapeutic device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. Clinical ground truth (e.g., patient outcomes, pathology) for efficacy in a clinical trial setting is not described in this 510(k) for the Luminex LL Laser System itself. The "ground truth" for this 510(k) is the established performance and safety profiles of the legally marketed predicate devices.
The sample size for the training set
- N/A. This device is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established
- N/A. This device is not an AI/ML algorithm.

Summary

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K063574

APPENDIX C

SUMMARY OF SAFETY AND EFFICACY (Per 21 CFR Part 807.92)

I.	General Information
Device Generic Name:	Low Level Therapeutic Laser
Trade Name:	Luminex LL Laser System
Device Classification:	Class II, Performance Standards21CFR Part 890.5500 - Infrared Lamp,Non-heating
Product Code:	NHN
Applicant Name and Address:	Medical Laser Systems, Inc.20 Baldwin DriveBranford, CT 60405203 / 481-2395Brian D. Richardson, President
Key Contact:	Miki KoltonRegulatory ConsultantGreenberg, Traurig, LLP800 Connecticut Ave. NW Suite 500Washington, DC 20006(202)331-3100mkolton@gtlaw.com
510(k) Number:	Pending

JAN 29 2007#### II. Device Description

III. Indication for Use

The Luminex Laser Therapy System is a non-heating, infrared tamp indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

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Predicate Devices IV.

The Luminex LL Laser System is substantially equivalent to other low level therapeutic lasers currently in commercial distribution. These predicate devices include the Microlight Corporation of America, Inc., MicroLight 830 Laser System (K010175), the Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657), and the Meridian Co., Ltd., Lapex 2000 (K034009).

V. Summary of the Technical Characteristics of the Laser System as Related to the Referenced Predicate Devices.

The Luminex LL Laser System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices use infrared diodes to emit invisible photonic energy to tissue. The Luminex LL Laser System and the aforementioned predicate devices have the same intended uses and similar technical and performance characteristics.

VI. Testing

Testing of the System includes functional performance testing and electrical safety testing. The Luminex LL Laser System is manufactured to comply with the FDA's Quality System Requlations and applicable standards for light emitting medical devices.

VII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the Luminex LL Laser System has the equivalent intended uses, with similar technical characteristics. The Luminex LL Laser System is designed to comply with the generally accepted therapeutic laser performance specifications as an adjunctive treatment for the relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

The Luminex LL Laser System performs as intended and does not raise any new questions of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Laser Systems, Inc. % Greenberg, Traurig, LLP Mr. Miki Kolton Regulatory Consultant 800 Connecticut Avenue, NW Suite 500 Washington, District of Columbia 20006

JAN 2 9 2007

Re: K063574

Trade/Device Name: Luminex LL Saser System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp. Regulatory Class: Class II Product Code: NHN Dated: November 28, 2006 Received: November 29, 2006

Dear Mr. Kolton:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Mr. Miki Kolton

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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In response to question #1 regarding indications for use: below is the revised page 16, "Indications for Use Statement" for your review. The indications for use have been revised to reflect the indications for use of the chosen predicate devices.

(Appendix A, Page 16)

APPENDIX A

Indications for Use Statement

510(k) Number (if known):

Pending Ko63574

Device Name:

Luminex LL Laser System

Indication for Use:

Probe	Indications for Use
830nm	Adjunctive use in the temporary relief of handand wrist pain associated with Carpal TunnelSyndrome

Prescription Use: X AND/OR Over the Counter Use: (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODpE)

vision Sign-O
Division of Cene Restorative
and Neurological vices

Vices

Regulation Number and Section

N/A