510(k) K013941 ยท GEX Powered Laser Surgical Instrument
PULSION FS LASER KERATOME
| Applicant | Intra Lase Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 27, 2002 |
| Received | Nov 29, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013941
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2003 | Intralase Corp Intralase FS Laser System.
Laser Keratome Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.