510(k) K082033 ยท GEX Powered Laser Surgical Instrument
NANNOLIGHT INTENSE PULSED LIGHT SYSTEM
| Applicant | Global USA Distribution, LLC, Minneapolis MN, US |
| Decision | Substantially Equivalent, Jul 31, 2008 |
| Received | Jul 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082033
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2009 | Sybaritic, Inc Sybaritic, NannoLight MP50.
Model Numbers and Description:
1.) 304207-MP 220 Volt, Multi-Platform configuration (able to attach optional
laser handpiece when purchas Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.