510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K863937Substantially Equivalent for Some Indications

Osram Ultramed 400 W

Osram GmbH, West Germany, DE / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K863937 is the FDA 510(k) clearance record for OSRAM ULTRAMED 400 W, a class II device, cleared for Osram GmbH on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list one 510(k) clearance for Osram GmbH. As of , FDA records show no recalls naming K863937.

Clearance record

Decision date
Received
(26 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Osram GmbH Postfach 90 06 20, West Germany, DE
Third party review
No

Clearances, product code FTC

Trailing 12 months
3 clearances under product code FTC in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FTC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20261