510(k) K131207 ยท HQF Laser, Ophthalmic
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
| Applicant | Surgical Instrument Engineering AG, Littleton CO, US |
| Decision | Substantially Equivalent, Oct 9, 2013 |
| Received | Apr 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131207
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2015 | Ziemer Usa Inc Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries. Terminated |
HQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.