GENTLEWAVES LED PHOTOMODULATION DEVICE by LIGHT BIOSCIENCE, LLC

This FDA 510(k) clearance letter for the GentleWaves LED Photomodulation Device does not contain the detailed information necessary to complete most of your request regarding acceptance criteria and study particulars. The letter primarily confirms substantial equivalence to a predicate device for marketing purposes and specifies the intended use.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not specified in the provided document. A 510(k) clearance letter does not typically detail the specific performance metrics or acceptance thresholds for a device, beyond confirming its "substantial equivalence" to a predicate device.
Reported Device Performance: Not included in the provided document.

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

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). These details would typically be found in the clinical study report, not the clearance letter.

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

Number of Experts: Not specified.
Qualifications: Not specified.

4. Adjudication Method for the Test Set:

Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No mention of an MRMC study or comparative effectiveness with human readers.

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

The device is a physical LED photomodulation device for treatment, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable in this context.

7. The Type of Ground Truth Used:

Not specified. For a device treating wrinkles, ground truth could involve clinical assessments (e.g., blinded physician ratings, photographic analysis, objective measures like skin elasticity), but this is not detailed here.

8. The Sample Size for the Training Set:

Not applicable as this is a physical medical device, not an AI algorithm requiring a training set in the conventional sense.

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

Not applicable for the same reason as point 8.

Summary of available information:

Device Name: GentleWaves LED Photomodulation Device
Indicated Use: Treatment of periorbital wrinkles and rhytides.
Regulatory Basis for Clearance: Substantial equivalence to a legally marketed predicate device, not necessarily based on a new, comprehensive clinical study detailed in this letter.

To obtain the detailed information you are requesting (acceptance criteria, study design, sample sizes, ground truth methodology, etc.), you would need to access the full 510(k) summary and potentially the underlying clinical study reports submitted to the FDA for this device, which are not part of this clearance letter.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2005

Light BioScience, L.L.C. c/o Mr. Robert T. Handren, Jr., M.S. President Handren Associates, Inc. 5818 Princess Caroline Place Leesburg, Florida 34748

Re: K031425

Trade/Device Name: GentleWaves LED Photomodulation Device 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: September 14, 2004 Received: September 15, 2004

Dear Mr. Handren:

This letter corrects our substantially equivalent letter of December 15, 2004 regarding the incorrect identification of the company as Light BioScience L.L.P. rather than the correct identification of the company as Light BioScience L.L. C.

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 intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendrerotator 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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The goneral 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 additional controls. Existing major regulations affecting your device can he found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FIDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Robert T. Handren, Jr., M.S.

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 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 continue 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Purvot

(Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K031425

Device Name: GentleWaves LED Photomodulation Device

Indications For Use:

The GentleWaves LED Photomodulation Device is indicated/intended for use in the treatment of periorbital wrinkles and rhytides.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office if Device Evaluation (ODE)

Musiam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_Ko31425

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.