510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812853Substantially Equivalent

Osram Uva Lamp

Osram GmbH, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812853 is the FDA 510(k) clearance record for OSRAM UVA LAMP, a class II device, cleared for Osram GmbH on under FDA product code IOB (Lamp, Infrared, Non Heating). FDA records list one 510(k) clearance for Osram GmbH. As of , FDA records show no recalls naming K812853.

Clearance record

Decision date
Received
(57 days to decision)
Product code
IOB Lamp, Infrared, Non Heating
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Osram GmbH 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IOB

Trailing 12 months

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

FDA records show no clearances under product code IOB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IOB, 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