Company ยท US
Topcon Medical Laser Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2018. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 25, 2018 | K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar Topcon Medical Laser Systems, Inc. | HQF |
| Nov 27, 2017 | K171488 | PSLT for PASCAL Streamline Topcon Medical Laser Systems, Inc. | HQF |
| May 15, 2013 | K123542 | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER Topcon Medical Laser Systems, Inc. | HQF |
| Aug 11, 2011 | K111108 | PASCAL STREAMLINE 577 (WITH ACCESSORIES) Topcon Medical Laser Systems, Inc. | HQF |
| Sep 25, 2009 | K092621 | PASCAL STREAMLINE PHOTOCOAGULATOR Topcon Medical Laser Systems, Inc. | HQF |
| Mar 3, 2005 | K043486 | PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 Topcon Medical Laser Systems, Inc. | GEX |
Latest recalls
| 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 | K123542 |
| Jul 19, 2013 | Topcon Medical Laser Systems, Inc PASCAL and PASCAL Streamline (532 nm.577 nm);
Treats the patient's eye. Terminated |
HQF | K100019 |