THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM

K024020 · Theralight, Inc. · FTC · Jan 17, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024020
• Device Name: THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
• Applicant: Theralight, Inc.
• Product Code: FTC · General, Plastic Surgery
• Decision Date: Jan 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TheraLight UV120-2 UVA / UVB Phototherapy System is intended for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the System UVB channel is indicated for the treatment of leukoderma.

Device Story

Microprocessor-controlled high-intensity UV light source; delivers targeted UVA/UVB phototherapy. User selects dose via front panel controls; light delivered through flexible lightguide and handpiece to localized 3/4" square skin patch. Protects neighboring healthy tissue. Used in clinical settings; operated by healthcare professionals. Output provides therapeutic UV exposure for dermatologic conditions; enables localized treatment of skin lesions.

Clinical Evidence

Bench testing only. System performance data (UVB output spectra) compared to predicate devices; found to be same or very similar.

Technological Characteristics

Microprocessor-controlled UV light source; flexible lightguide and handpiece delivery system; targeted 3/4" square spot size; UVA/UVB emission.

Indications for Use

Indicated for patients with psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma (UVB channel only) requiring PUVA photochemistry or UVB phototherapy.

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

• TheraLight, Inc. UV120-2 UVA / UVB Phototherapy System (K022165)
• Lumenis, Ltd. BClear UVB Phototherapy System (K020591)
• PhotoMedex, Inc. XTRAC Excimer Laser Phototherapy System

Submission Summary (Full Text)

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JAN 1 7 2003

# 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 92008-6616 |
| Telephone: | [phone] |
| Contact: | Kevin E. Daly |
| Date Prepared: | December 2, 2002 |
| Device Trade Name: | UV120-2 UVA / UVB Phototherapy System |
| Device Common Name: | Targeted UVA / UVB Phototherapy System |
| Device Classification Name: | Ultraviolet lamp for dermatologic / skin<br>disorders (ref. 21 CFR 878.4630) |
| Predicate Devices: | TheraLight, Inc.<br>UV120-2 UVA / UVB Phototherapy System<br>K022165 |
| | Lumenis, Ltd.<br>BClear UVB Phototherapy System<br>K020591 |
| | PhotoMedex, Inc.<br>XTRAC Excimer Laser Phototherapy System |

K020847

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#### Device Description:

The TheraLight UV120-2 UVA / UVB Phototherapy System is a microprocessorcontrolled, high-intensity ultraviolet light source. The desired dose of UVA or UVB light is selected using controls on the System front panel. The System provides "targeted" phototherapy, whereby the specified dose of UVA or UVB light is delivered via a flexible Lightguide and Handpiece. The System delivers a homogenous UV light dose to a localized ¾" square patch of skin without exposure to neighboring, healthy tissues.

### Intended Use:

The TheraLight UV120-2 UVA / UVB Phototherapy System is intended for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the System UVB channel is indicated for the treatment of leukoderma.

#### Performance Data:

The TheraLight UV120-2 UVA / UVB Phototherapy System currently is indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema) and seborrheic dermatitis. System performance data (UVB output spectra) is the same or very similar that for the claimed predicate devices.

#### Conclusion:

On the basis of the information provided in this Summary, TheraLight, Inc. believes the UV120-2 UVA / UVB Phototherapy System is substantially equivalent to legally commercialized predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

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

Re: K024020

Trade/Device Name: UV120-2 UVA/UVB Phototherapy System Regulation Number: 878.4630 Regulation Name: Ultraviolet lamp for dermatologic/skin disorders Regulatory Class: Class II Product Code: FTC Dated: December 3, 2002 Received: December 5, 2002

Dear Mr. Daly:

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

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Page 2 -- Mr. Kevin E. Daly

(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 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). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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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510(k) Number (if known): 上のスイリ20

Device Name: TheraLight UV120-2 UVA/UVB Phototherapy System

Indications for Use:

The TheraLight UV120-2 UVA / UVB Phototherapy System is indicated for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the System UVB channel is indicated for the treatment of leukoderma.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Optional Format 3-10-98)

ivision Sign-Off Jivision of General, Restorative and Neurological Devices

K024020