Topcon Medical Laser Systems, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2405-2016 | Class II | Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single sh | July 15, 2016 |
| Z-1774-2013 | Class II | PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye. | March 27, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | May 25, 2018 |
| K171488 | PSLT for PASCAL Streamline | November 27, 2017 |
| K123542 | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER | May 15, 2013 |
| K111108 | PASCAL STREAMLINE 577 (WITH ACCESSORIES) | August 11, 2011 |
| K092621 | PASCAL STREAMLINE PHOTOCOAGULATOR | September 25, 2009 |
| K043486 | PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 | March 3, 2005 |