510(k) K012682 ยท GEX Powered Laser Surgical Instrument
REPROCESSED LASER PROBE
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Nov 8, 2001 |
| Received | Aug 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012682
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Sterilmed Inc Laser Probe Model #': SYN55.26.25
Reprocessed laser probes are part of a laser delivery system and are used in opthalmic procedures where laser energy is the mode of treatment. Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.