510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K102758Substantially Equivalent

Trulight 5520 and Trulight 5320

Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg, Charleston SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102758 is the FDA 510(k) clearance record for TRULIGHT 5520 AND TRULIGHT 5320, a class II device, cleared for Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg on under FDA product code FSY (Light, Surgical, Ceiling Mounted). FDA records list 2 510(k) clearances for Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg, from to . As of , FDA records show 2 recalls naming K102758.

Clearance record

Decision date
Received
(33 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
Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg 1046 Legrand Blvd., Charleston SC
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