510(k) K150323 ยท OOE Ophthalmic Femtosecond Laser
FEMTO LDV Z8 Surgical Laser
| Applicant | Sie Ag,Surgical Instrument Engineering, Port, CH |
| Decision | Substantially Equivalent, Oct 23, 2015 |
| Received | Feb 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150323
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2018 | SIE AG, Surgical Instrument Engineering The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use Terminated |
OOE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.