ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)— 510(k) K091246

Name: FDA 510(k) clearance K091246
Creator: U.S. Food and Drug Administration
Published: 2009-09-28

Substantially Equivalent

Trumpf Medizin Systeme GmbH + Co. KG

FDA 510(k) clearance K091246 for ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M), Substantially Equivalent on 2009-09-28. Applicant: Trumpf Medizin Systeme GmbH + Co. KG. Device class: 2.

Clearance details

Applicant: Trumpf Medizin Systeme GmbH + Co. KG
Product code: Code FSS
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2009-04-27
Decision date: 2009-09-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Charleston, SC, US

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