510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K070442Substantially Equivalent

Powerled Surgical Light System

Maquet Cardiovascular Us Sales, LLC, Rochester NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070442 is the FDA 510(k) clearance record for POWERLED SURGICAL LIGHT SYSTEM, a class II device, cleared for Maquet S.A. on under FDA product code FSY (Light, Surgical, Ceiling Mounted). FDA records list 5 510(k) clearances for Maquet Cardiovascular Us Sales, Llc, from to . As of , FDA records show 2 recalls naming K070442.

Clearance record

Decision date
Received
(29 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
Maquet S.A. 1777 E. Henrietta Rd., Rochester NY
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