510(k) K001211 ยท GEX Powered Laser Surgical Instrument
MODIFICATION TO INTRALASE 600C LASER KERATOME
| Applicant | Intra Lase Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 4, 2000 |
| Received | Apr 14, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001211
| 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.