510(k) K111213 ยท GEX Powered Laser Surgical Instrument
VISION ONE LASER SYSTEM
| Applicant | Lumenis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jul 25, 2011 |
| Received | May 2, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2013 | Lumenis, Inc. Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053.
Intended for use in the treatment of ocular pathology. Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.