UVBIOTEK MODELS 3200B AND 4000B

K051330 · Medtek Lighting Corporation · FTC · Nov 18, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051330
• Device Name: UVBIOTEK MODELS 3200B AND 4000B
• Applicant: Medtek Lighting Corporation
• Product Code: FTC · General, Plastic Surgery
• Decision Date: Nov 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

to provide ultraviolet (UVB) radiation of the body to photoactivate a drug in the treatment of dermatologic disorders.

Device Story

The UVBio Tek 3200B / 4000B is a medical ultraviolet lamp system designed for dermatologic phototherapy. The device emits UVB radiation to the patient's body to photoactivate therapeutic drugs used in the treatment of skin conditions. It is intended for use in a clinical setting under the supervision of a healthcare provider. The device provides controlled UV exposure to facilitate clinical treatment protocols, aiding in the management of dermatologic disorders.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultraviolet lamp system for dermatologic disorders; emits UVB radiation; Class II device; regulated under 21 CFR 878.4630; product code FTC.

Indications for Use

Indicated for patients requiring ultraviolet (UVB) radiation therapy to photoactivate drugs for the treatment of dermatologic disorders. Prescription use only.

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.

Submission Summary (Full Text)

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## NOV 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtek Lighting Corp. c/o Robert T. Wagner, CEO American Export Group & International Services, Inc. 2840 Scherer Drive N. St. Petersburg, Florida 33716

Re: K051330

Trade/Device Name: UVBio Tek 3200B / 4000B Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: October 7, 2005 Received: October 11, 2005

Dear Mr. Wagner:

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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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/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Mark A. Mellema

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

## KOXISSO

UVBioTek 3200B / 4000B, produced by MedTek Lighting Corp, Hudson Falls, NY

Indications for Use:

Sec. 878.4630, Ultraviolet lamp for dermatologic disorders - to provide ultraviolet (UVB) radiation of the body to photoactivate a drug in the treatment of dermatologic disorders.

Prescription Use X (21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Mellkiser

051330

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

510(k) Number

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