510(k) K081565 ยท HQF Laser, Ophthalmic
INTEGRE PRO, MODEL L2RY
| Applicant | Ellex Medical Pty, Ltd., Adelaide, South Australia, AU |
| Decision | Substantially Equivalent, Jul 2, 2008 |
| Received | Jun 4, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081565
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2023 | Ellex Medical Pty Ltd. Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532
Spare, Optics Bench V2, L2G/LP6G Open, Classified |
HQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.