The following data is part of a premarket notification filed by Optimedica Corporation with the FDA for Pascal Streamline Photocoagulator.
| Device ID | K100019 |
| 510k Number | K100019 |
| Device Name: | PASCAL STREAMLINE PHOTOCOAGULATOR |
| Classification | Laser, Ophthalmic |
| Applicant | OPTIMEDICA CORPORATION 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
| Contact | Darlene Crockett-billing |
| Correspondent | Darlene Crockett-billing OPTIMEDICA CORPORATION 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-05 |
| Decision Date | 2010-05-04 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PASCAL STREAMLINE PHOTOCOAGULATOR 77708955 not registered Dead/Abandoned |
OptiMedica Corporation 2009-04-07 |