VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100

K061295 · Theralight, Inc. · FTC · May 25, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061295
• Device Name: VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
• Applicant: Theralight, Inc.
• Product Code: FTC · General, Plastic Surgery
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VersaClear Skin Therapy System UVA (350mm) Light Module is indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.

Device Story

The VersaClear Skin Therapy System UVA (350nm) Light Module is an AC-powered illumination source emitting UVA radiation. It operates at a peak wavelength of 350nm (±5nm) with a nominal skin irradiance of 10-35 mW/cm2. The device is intended for use in providing phototherapy for diagnosed skin disorders. It functions as a light module for dermatologic treatment. Clinical benefit is derived from the application of specific ultraviolet radiation to the skin as prescribed for a patient's condition.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

120/240V 50/60 Hz AC-powered UVA illumination source. Peak wavelength 350nm (±5nm); bandwidth 40nm (FWHM); nominal skin irradiance 10-35 mW/cm2. Class II device under 21 CFR 878.4630.

Indications for Use

Indicated for individuals requiring ultraviolet radiation therapy for diagnosed skin disorders.

Regulatory Classification

Identification

An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.

Predicate Devices

• Flex Controlled Phototherapy Equipment (K050695)

Submission Summary (Full Text)

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MAY 2 5 2006

Attachment 4
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## 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 105<br>Carlsbad, CA 92008 |
| Telephone: | [phone] |
| Contact: | Kevin E. Daly<br>Chief Operating Officer |
| Date Prepared: | May 13, 2006 |
| Device Trade Name: | VersaClear™ Skin Therapy System UVA (350nm)<br>Light Module |
| Device Common Name: | VersaClear™ Skin Therapy System UVA (350nm)<br>Light Module |
| Device Classification Name: | Ultraviolet lamp for dermatologic / skin disorders<br>(ref. 21 CFR 878.4630). |
| Predicate Devices: | Flex Controlled Phototherapy Equipment<br>Daavlin Distributing Company<br>K050695 |

### Device Description:

The VersaClear™ Skin Therapy System UVA (350mm) Light Module is a 120/240V 50/60 Hz AC illumination source that emits UVA radiation with a peak at 350mm ± S mm.

#### Intended Use and Indications for Use:

The VersaClear™ Skin Therapy System UVA (350mm) Light Module is indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.

#### Performance Data:

The VersaClear™ Skin Therapy System UVA (350nm) Light Module emits UVA radiation at a peak of 350mm +5mm and a bandwidth (Full Width at Half Maximum) of 40nm, and a nominal skin irradiance of from 10-35 mW/cm2.

### Conclusion:

The VersaClear Skin Therapy System is substantially equivalent to legally commercialized UV phototherapy devices. Comments of

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 5 2006

TheraLight, Inc. % Mr. Kevin E. Daly Chief Operating Officer 2794 Loker Avenue West, Suite 105 Carlsbad, California 92010

Re: K061295

K001295
Trade/Device Name: VersaClear™ Skin Therapy UVA (350nm) Light Module Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: May 8, 2006 Received: May 9, 2006

Dear Mr. Daly:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 conninered pror to Thay 20, 1978, in accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, maniev of the Act include requirements for annual registration, listing of general controls proficturing 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 If your device is classified (600 a0070) als. Existing major regulations affecting your device can may be subject to back adden accept 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 that I Dr head statutes and regulations administered by other Federal agencies. You must or any I 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. Kevin E. Daly

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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#### Indications For Use

510(k) Number (if known): K061295

Device Name: VersaClear™ Skin Therapy System UVA (350nm) Light Module

Indications for Use:

The VersaClear Skin Therapy System UVA (350mm) Light Module is indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

ﻢ .

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

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

> H, Office of Device Evaluation (ODE) Concurrence of

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

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KOGI 295 510(k) Numbe