510(k) K013402 ยท GEX Powered Laser Surgical Instrument
VISULAS 532S
| Applicant | Carl Zeiss, Inc., Thornwood NY, US |
| Decision | Substantially Equivalent, Nov 14, 2001 |
| Received | Oct 15, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013402
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Carl Zeiss Ophthalmic Systems Inc Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye. Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.