The VersaClear Skin Therapy System is generally indicated to treat dermatological conditions. Blue light modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light for the treatment of moderate inflammatory acne vulgaris, and for use alone in the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.

Device Description

The VersaClear™ Skin Therapy System is a 120/240V 50/60 Hz AC illumination source consisting of one or more light modules. A set of light modules emits a specific narrow spectrum of light, namely blue (420 ± 2nm), red (615 ± 3nm), or UVA (368 ± 3nm). The light modules are mounted on a positioning arm attached to a mobile or stationary pedestal, a wall, or a countertop. This flexible design accommodates varying office spatial settings, and allows for the treatment of patients who are sitting, reclining, or lying down. Light modules are interchangeable to maximize System versatility.

AI/ML Overview

The document provided is a 510(k) summary for the VersaClear™ Skin Therapy System. It states that the device is substantially equivalent to predicate devices based on its performance characteristics and that there are no new safety or efficacy issues. However, it does not include a detailed study or specific acceptance criteria with reported performance data for the VersaClear™ Skin Therapy System itself.

Instead, the submission relies on the concept of "substantial equivalence" to predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device that was already on the market before May 28, 1976 (preamendments device) or to a device that has been reclassified.

Therefore, many of the requested details about a specific study and its acceptance criteria are not present in this document.

Here's what can be extracted and what cannot:

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

Acceptance Criteria: Not explicitly stated as pass/fail thresholds in this document for the VersaClear™ System. The implicit "acceptance criterion" is proving substantial equivalence to predicate devices, meaning the performance characteristics are similar enough not to raise new safety/efficacy concerns.
Reported Device Performance: The document states, "The performance characteristics of the VersaClear System are substantially similar to the cited predicate devices. The technological differences do not raise new types of safety or efficacy issues." No specific quantitative performance data for the VersaClear™ System is provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not provided. The document does not describe a new study with a test set for the VersaClear™ System. It relies on the performance of predicate devices.

3. 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):

Not applicable/Not provided. No new test set data is discussed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided. No new test set data is discussed.

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 a light therapy system, not an AI-driven image analysis or diagnostic tool involving human readers.

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

Not applicable. This device is a light therapy system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable/Not provided. No new study data is discussed. The "ground truth" for the substantial equivalence claim relies on the established safety and efficacy of the predicate devices for their respective indications.

8. The sample size for the training set:

Not applicable/Not provided. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable/Not provided. This is not an AI/machine learning device.

Summary based on the provided text:

Criteria / Study Detail	Information from Document
Acceptance Criteria	Not explicitly defined with quantitative thresholds for the VersaClear™ System in this document. The stated basis for clearance is substantial equivalence to predicate devices, meaning performance is similar enough such that no new safety or efficacy issues are raised.
Reported Device Performance	"The performance characteristics of the VersaClear System are substantially similar to the cited predicate devices. The technological differences do not raise new types of safety or efficacy issues." No specific numerical performance data (e.g., treatment efficacy rates, adverse event rates) for the VersaClear™ System itself are provided in this summary. Instead, it relies on the established performance of the predicate devices for their respective indications.
Sample Size (Test Set)	Not applicable. No new study for the VersaClear™ System is detailed.
Data Provenance (Test Set)	Not applicable.
Number & Qualifications of Experts (Test Set Ground Truth)	Not applicable.
Adjudication Method (Test Set)	Not applicable.
MRMC Comparative Effectiveness Study	Not applicable. This is not an AI/diagnostic device.
Standalone Performance Study	Not applicable. Not an algorithm.
Type of Ground Truth Used	The "ground truth" implicitly relies on the established safety and efficacy profiles of the predicate devices, which would have been demonstrated through clinical studies, pathology, or outcomes data during their initial clearances.
Sample Size (Training Set)	Not applicable. Not an AI/machine learning device.
How Ground Truth for Training Set Established	Not applicable. Not an AI/machine learning device.

Conclusion from document:

The VersaClear™ Skin Therapy System received 510(k) clearance based on its substantial equivalence to previously cleared predicate devices. The submission affirms that the performance characteristics are "substantially similar" and "technological differences do not raise new types of safety or efficacy issues," thus eliminating the need for a de novo performance study with specific acceptance criteria in this submission.

Summary

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SEP 2 0 2005

Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K05/259". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with distinct strokes and curves.

510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

Submitter's name:	TheraLight, Inc.
Submitter's Address:	2794 Loker Avenue West, Suite 105Carlsbad, CA 92008
Telephone:	(760) 930-8000
Contact:	Kevin E. DalyChief Operating Officer
Date Prepared:	May 13, 2005
Device Trade Name:	VersaClear™ Skin Therapy System
Device Common Name:	VersaClear™ Skin Therapy System
Device Classification Name:	Laser surgical instrument for use in general andplastic surgery and in dermatology (ref. 21 CFR878.4810); Ultraviolet lamp for dermatologic / skindisorders (ref. 21 CFR 878.4630).
Predicate Devices:	Blu-U Photodynamic Therapy IlluminatorDusa Pharmaceuticals, Inc.K031805
	Omnilux BluePhoto Therapeutics, Ltd.K030883
	Omnilux RedPhoto Therapeutics, Ltd.K030426
	Omnilux Revive and BluePhoto Therapeutics, Ltd.K043329
	HOUVA II UVANational Biological CorporationK885025
	HOUVA 3 Phototherapy SystemNational Biological CorporationK041212
Predicate Devices (cont'd):	UV 1000
	Waldmann Lichttechnik
	K841795

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Device Description:

Intended Use and Indications for Use:

The VersaClear System is intended to provide phototherapeutic light to the body. The VersaClear is generally indicated to treat dermatological conditions. Blue light modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light for the treatment of moderate inflammatory acne vulgaris, and for use alone in the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.

Performance Data:

The performance characteristics of the VersaClear System are substantially similar to the cited predicate devices. The technological differences do not raise new types of safety or efficacy issues. On this basis, the VersaClear System is substantially equivalent to the predicate devices.

Conclusion:

On the basis of the information provided in this Summary, TheraLight believes that the VersaClear Skin Therapy System is substantially equivalent to legally commercialized predicate devices.

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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 features a stylized eagle with three stripes forming its body and head. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2005

Mr. Kevin E. Daly Chief Operating Officer TheraLight, Inc. 2794 Loker Avenue West, Suite 105 Carlsbad, California 92008-6616

Re: K051259 Trade/Device Name: VersaClear™ Skin Therapy System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX, FTC Dated: September 2, 2005 Received: September 6, 2005

Dear Mr. Daly:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection o re(t) possession is substantially equivalent (for the indications felerenced above and nave decembers and marketed predicate devices marketed in interstate for use stated in the encrosate) to regard as a many and call be vice Amendments, or to commerce prior to May 20, 1976, the exactions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosmetic Ac. (710t) that do not require to the general controls provisions of the Act. The 1 ou may, merelore, manel the Act include requirements for annual registration, listing of general controls provisions of tactice, 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 If your device is classified (500 as roy als. Existing major regulations affecting your device can may be subject to sublications, 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 r least be advised that I Dris issualles syour device complies with other requirements of the Act that I Drehan statutes and regulations administered by other Federal agencies. You must or any I coolar statutes and submitted to: registration and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 007, adoling (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic fordling the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Kevin E. Daly

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

Sincerely yours,

Barbara Budrin

Mark N. Melkerson Acting 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 STATEMENT

510(k) Number (if known): K051259

Device Name: VersaClear™ Skin Therapy System

Indications for Use:

The VersaClear Skin Therapy System is generally indicated to treat dermatological The Versachour Dimi- modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light modules vulgaris. Technique of moderate inflammatory acne vulgaris, and for use alone the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated of superietar, beling in vasoa.ca, are ultraviolet radiation therapy for diagnosed skin disorders.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Chabala Buchup for MKM

Division of Ge neral. Restorative. and Neurological De

510(k) Number.

Page 13a of 35

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.