510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140460Substantially Equivalent

Mach LED 2Sc

Dr. Mach GmbH & Co. KG, Norderstedt, Schleswig-Holstein, DE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140460 is the FDA 510(k) clearance record for MACH LED 2SC, a class II device, cleared for Dr. Mach GmbH & Co. KG on under FDA product code FSY (Light, Surgical, Ceiling Mounted). FDA records list 4 510(k) clearances for Dr. Mach GmbH & Co. KG, from to . As of , FDA records show no recalls naming K140460.

Clearance record

Decision date
Received
(38 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
Dr. Mach GmbH & Co. KG Fehmarnstrasse 31, Norderstedt, Schleswig-Holstein, DE
510(k) summary
Summary PDF
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