BIRTCHER UV LAMP

K973865 · Medfaxx, Inc. · MXG · Feb 26, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K973865
• Device Name: BIRTCHER UV LAMP
• Applicant: Medfaxx, Inc.
• Product Code: MXG · General, Plastic Surgery
• Decision Date: Feb 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Treatment of open wounds and dermatologic disorders.

Device Story

The V-254 is a medical device intended for the treatment of open wounds and dermatologic disorders. The document provides no specific details regarding the device's physical mechanism, input/output modalities, or operational context beyond its classification as a device for wound and dermatologic care.

Indications for Use

Indicated for the treatment of open wounds and dermatologic 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 1999

Mr. Bob Johnson Vice President MedFaxx, Inc. P.O. Box 17827 Raleigh, North Carolina 27619

Re: K973865 Trade Name: V-254 Regulatory Class: Unclassified Product Code: MXG Dated: November 30, 1998 Received: November 30, 1998

Dear Mr. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave lovice your boomer be device is substantially equivalent (for the indications for above and we have docements alevices marketed in interstate commerce prior to use stated in the cheropent date of the Medical Device Amendments, or to devices that May 20, 1770, the enavance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costlicte Act (110). Tournal) , rail controls provisions of the Act include requirements for provisions or ation, 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 (Premarket Approval), it may be subject to such additional controls. Existing major (1 romance I Ipprovial), or device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Bob Johnson

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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2004

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510(k) Number (if known): K 38 ك Device Name: Indications For Use: bacterici tor ત્વ વ matologic disorders C Q4 the 14 Treatment f open a h tor the Qu d 0 4 4 4 6 600 WOUW

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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Division of General Restorative Devices

| 510(k) Number | K973865 |
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Prescription Use (Per 21 CFR 801.

OR

Over-The-Counter Use

(Optional Format 1-2-96)