510(k) K112154 ยท HQF Laser, Ophthalmic
FEMTO LDV
| Applicant | Sie Ag,Surgical Instument Engineering, Greenwood Village CO, US |
| Decision | Substantially Equivalent, Mar 16, 2012 |
| Received | Jul 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112154
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2014 | Ziemer Usa Inc 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring Terminated |
HQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.