The following data is part of a premarket notification filed by Topcon Medical Laser Systems, Inc. (tmls) with the FDA for Pascal Synthesis Twinstar Ophthalmic Scanning Laser System.
| Device ID | K170409 |
| 510k Number | K170409 |
| Device Name: | PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Topcon Medical Laser Systems, Inc. (TMLS) 606 Enterprise Court Livermore, CA 94550 |
| Contact | Sweta Srivastava |
| Correspondent | Pamela M. Buckman Pamela M. Buckman, MSN 2800 Pleasant Hill Rd., Suite 175 Pleasant Hill, CA 94523 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-10 |
| Decision Date | 2017-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855005006188 | K170409 | 000 |
| 00855005006171 | K170409 | 000 |
| 00855005006263 | K170409 | 000 |
| 00855005006232 | K170409 | 000 |
| 00813125015596 | K170409 | 000 |
| 00813125015589 | K170409 | 000 |