510(k) K102758 ยท FSY Light, Surgical, Ceiling Mounted
TRULIGHT 5520 AND TRULIGHT 5320
| Applicant | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg, Charleston SC, US |
| Decision | Substantially Equivalent, Oct 26, 2010 |
| Received | Sep 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102758
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2015 | Trumpf Medical Systems, Inc. Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5 Completed |
FSY | None listed |
| Feb 13, 2012 | Trumpf Medical Systems, Inc. Surgical lighting systems iLED and TruLight in use with the ALC+ function.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a Terminated |
FSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.