510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120392Substantially Equivalent

Chromophare F 628 and F 528

Berchtold GmbH & Co. KG, Tuttlingen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120392 is the FDA 510(k) clearance record for CHROMOPHARE F 628 AND F 528, a class II device, cleared for Berchtold GmbH & Co. KG on under FDA product code FSY (Light, Surgical, Ceiling Mounted). FDA records list 2 510(k) clearances for Berchtold GmbH & Co. KG, from to . As of , FDA records show 2 recalls naming K120392.

Clearance record

Decision date
Received
(8 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
Berchtold GmbH & Co. KG Ludwigstaler St. 25, Tuttlingen, DE
510(k) summary
Summary PDF
Third party review
Yes

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