510(k) K100019 ยท HQF Laser, Ophthalmic
PASCAL STREAMLINE PHOTOCOAGULATOR
| Applicant | Optimedica Corporation, Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 4, 2010 |
| Received | Jan 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100019
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2013 | Topcon Medical Laser Systems, Inc PASCAL and PASCAL Streamline (532 nm.577 nm);
Treats the patient's eye. Terminated |
HQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.