510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954169Substantially Equivalent

Hanaulux Blue 30 & 80

Heraeus Med GmbH, Hanau, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954169 is the FDA 510(k) clearance record for HANAULUX BLUE 30 & 80, a class II device, cleared for Heraeus Med GmbH on under FDA product code FSY (Light, Surgical, Ceiling Mounted). FDA records list 3 510(k) clearances for Heraeus Med GmbH, from to . As of , FDA records show one recall naming K954169.

Clearance record

Decision date
Received
(149 days to decision)
Product code
FSY Light, Surgical, Ceiling Mounted
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Heraeus Med GmbH Heraeusstrasse 12-14, Hanau, DE
510(k) summary
Summary
Third party review
No

Clearances, product code FSY

Trailing 12 months

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

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