510(k) K123542 ยท HQF Laser, Ophthalmic
PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
| Applicant | Topcon Medical Laser Systems, Inc., Pleasant Hill CA, US |
| Decision | Substantially Equivalent, May 15, 2013 |
| Received | Nov 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123542
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2016 | Topcon Medical Laser Systems, Inc Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed
conventionally. Terminated |
HQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.