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  |