510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973865Substantially Equivalent

Birtcher UV Lamp

Medfaxx, Inc., Raleigh NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973865 is the FDA 510(k) clearance record for BIRTCHER UV LAMP, a class II device, cleared for Medfaxx, Inc. on under FDA product code MXG (Lamp, Uvc, (For Treating Skin And Wounds)). FDA records list one 510(k) clearance for Medfaxx, Inc. As of , FDA records show no recalls naming K973865.

Clearance record

Decision date
Received
(508 days to decision)
Product code
MXG Lamp, Uvc, (For Treating Skin And Wounds)
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Medfaxx, Inc. P.O. Box 17827, Raleigh NC
510(k) summary
Statement
Third party review
No

Clearances, product code MXG

Trailing 12 months

FDA records hold no clearances under product code MXG in the trailing twelve months.

FDA records show no clearances under product code MXG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MXG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260