PHILIPS PLS9W/12/2P UVB

K021514 · Philips Lighting Co. · FTC · May 16, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021514
• Device Name: PHILIPS PLS9W/12/2P UVB
• Applicant: Philips Lighting Co.
• Product Code: FTC · General, Plastic Surgery
• Decision Date: May 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended function of the UV-B ultraviolet lamp is therapy for Psoriasis and Vitiligo.

Device Story

Philips PL-S 9W/12/2P UV-B is a 9-watt ultraviolet lamp designed for dermatological therapy. It emits UV-B radiation used in clinical settings to treat Psoriasis and Vitiligo. The device operates as a light source component; it is integrated into larger phototherapy systems. Healthcare providers use the lamp to deliver targeted UV-B exposure to affected skin areas. The therapeutic benefit is derived from the UV-B light's effect on skin cells, aiding in the management of these dermatological conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technical comparison of output characteristics to legally marketed predicate devices.

Technological Characteristics

9W UV-B lamp; 60V; G23 base; 167mm maximum overall length. Ultraviolet light source for dermatological disorders. Class II device (Product Code: FTC).

Indications for Use

Indicated for patients requiring ultraviolet light therapy for the treatment of Psoriasis and Vitiligo.

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

• TL20W/12/RS
• TL40W/12/RS
• TL100W/12 UV B

Submission Summary (Full Text)

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Kǒ21514

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Image /page/0/Picture/2 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The word is black and the background is white.

MAY 1 6 2002

EXHIBIT 2

# Philips Lighting Company

### 510K SUMMARY STATEMENT

| Company Name: | Philips Lighting Company<br>200 Franklin Square Drive<br>Somerset, NJ 08875-6800 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Toni J. Hoffmann<br>Corporate Quality Analyst |
| Telephone: | 732-563-3081 |
| Trade Names: | Philips PL-S 9W/12/2P UV-B |
| Common Name: | UVB Lamps |
| Classification: | Light, Ultraviolet, Dermatological |
| Description: | Philips PL-S 9W/12/2P UV-B<br>Watts - 9<br>Volts - 60<br>Base - G23<br>Length - max OAL - 167 mm |
| Intended Use: | The intended function of the UV-B ultraviolet lamp is therapy<br>for Psoriasis and Vitiligo. |
| Equivalence: | Substantial equivalence previous devices. Lamps are different<br>dimensionally but have substantially equivalent outputs.<br>TL20W/12/RS<br>TL40W/12/RS<br>TL100W/12 UV B |

Ref: FDA-510K Summary Statement File: 14.01.23

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200 Franklin Square Drive
P.O. Box 6800 Somerset, NJ 08875-6800 Tel: [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 6 2002

Ms. Toni J. Hoffman Corporate Quality Analyst Philips Lighting Company 200 Franklin Square Drive Somerset, NJ 08875-6800

Re: K021514 Trade/Device Name: Philips PLS9W/12/2P UV-B Regulation Number: 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: May 7, 2002 Received: May 9, 2002

Dear Ms. Hoffman:

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 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.

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Page 2 - Ms. Toni J. Hoffman

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Muriam C. Provost

Por 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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### Philips Lighting Company

## EXHIBIT 3

### INDICATION FOR USE STATEMENT

510(k) Number (if known):

): K021514

Device Name:

Philips PLS9W/12/2P UV-B

The intended function of the UV-B ultraviolet lamp is therapy for Psoriasis and Vitiligo.

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

Concurrence of DCRH, Office of Device Evaluation (ODE)

Muriam C. Provost

f General. Restorative and Neurological Devices

Prescription Use
510(k) Number K021514
(Per 21 CRF 8001.109) OR Ov

Over-the-Counter Use

(Optional Format 1-2-96)

Image /page/3/Picture/17 description: The image shows the ISO 9001 KEMA CERT logo. The logo includes the text "ISO 9001" in bold letters above "KEMA CERT". Below that, it states "Accredited by the Dutch Council for Accreditation (RwA)" and "Accredited by the Registrar Accreditation Board (RAB)". The logo also contains a circular symbol with a triangle inside.

A division of Philips Electronics North America Corporation 200 Franklin Square Drive P.O. Box 6800 Somerset, NJ 08875-6800 Tel: [phone]