The following data is part of a premarket notification filed by Topcon Medical Laser Systems, Inc with the FDA for Pascal Streamline 577 (with Accessories).
| Device ID | K111108 |
| 510k Number | K111108 |
| Device Name: | PASCAL STREAMLINE 577 (WITH ACCESSORIES) |
| Classification | Laser, Ophthalmic |
| Applicant | TOPCON MEDICAL LASER SYSTEMS, INC 3130 CORONADO DRIVE Santa Clara, CA 95054 |
| Contact | John Jossy |
| Correspondent | John Jossy TOPCON MEDICAL LASER SYSTEMS, INC 3130 CORONADO DRIVE Santa Clara, CA 95054 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-20 |
| Decision Date | 2011-08-11 |
| Summary: | summary |