MXGClass II

Lamp, Uvc, (for Treating Skin And Wounds)

General, Plastic Surgery · 21 CFR 878.4630

MDR events1All time

Recalls1All time

Registered firms1Currently listed

510(k) clearances1All time

Recent MDR events

1 adverse event reports on file

UV LIGHTSep 18, 2013
OtherMW5031903

Event type breakdown

Other1

Most-reported manufacturers

Recalls

1 recall events for this product code

Harris Medical Resources
TerminatedJun 16, 2010
Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or manufacturer, packer or distributor. It is packaged with
The Harris UV Lamp was promoted for sub-lingual treatment of HIV/AIDS; Hepatitis B; Hepatitis C; Malaria, Typhoid, Amoeba Infections and other blood diseases. The product was marketed without a 510(k), or an approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE). Questions are directed to the firm at 773-583-7500.
Z-1808-2010 · View FDA record ↗

Registered firms

1 firms currently registered for this product code

Micro Medical Devices, Inc.
Calabasas, CA, US

510(k) clearances

1 clearances for this product code

Medfaxx, Inc.Feb 26, 1999
K973865 · BIRTCHER UV LAMP