510(k) K100746 ยท GEX Powered Laser Surgical Instrument
FIBER ONE
| Applicant | American Medical Systems, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 11, 2010 |
| Received | Mar 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100746
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2010 | AMS Innovative Center - San Jose GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA
The XPS Laser system is indicated for surg Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.