The following data is part of a premarket notification filed by Topcon Medical Laser Systems, Inc with the FDA for Pascal Streamline Photocoagulator.
| Device ID | K092621 | 
| 510k Number | K092621 | 
| Device Name: | PASCAL STREAMLINE PHOTOCOAGULATOR | 
| 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 | Special | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2009-08-26 | 
| Decision Date | 2009-09-25 | 
| Summary: | summary | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() PASCAL STREAMLINE PHOTOCOAGULATOR  77708955  not registered Dead/Abandoned  | 
        OptiMedica Corporation  2009-04-07  |