The following data is part of a premarket notification filed by Topcon Medical Laser Systems, Inc. with the FDA for Pslt With Pascal Synthesis, Pslt With Pascal Synthesis Twinstar.
| Device ID | K180402 |
| 510k Number | K180402 |
| Device Name: | PSLT With PASCAL Synthesis, PSLT With PASCAL Synthesis TwinStar |
| Classification | Laser, Ophthalmic |
| Applicant | Topcon Medical Laser Systems, Inc. 606 Enterprise Ct. Livermore, CA 94550 |
| Contact | Sweta Srivastava |
| Correspondent | Sweta Srivastava Topcon Medical Laser Systems, Inc. 606 Enterprise Ct. Livermore, CA 94550 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-14 |
| Decision Date | 2018-05-25 |
| Summary: | summary |