510(k) K041598 ยท HQF Laser, Ophthalmic
LASEREX, MODEL LP4532
| Applicant | Ellex Medical Pty, Ltd., Adelaide, South Australia, AU |
| Decision | Substantially Equivalent, Oct 6, 2004 |
| Received | Jun 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041598
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2007 | Ellex USA Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA. Terminated |
HQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.