The following data is part of a premarket notification filed by Optimedica Corporation with the FDA for Pascal Photocoagulator, Pascal-us.
| Device ID | K091666 |
| 510k Number | K091666 |
| Device Name: | PASCAL PHOTOCOAGULATOR, PASCAL-US |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OPTIMEDICA CORPORATION 155-A MOFFIT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
| Contact | Darlene Crockett-billig |
| Correspondent | Darlene Crockett-billig OPTIMEDICA CORPORATION 155-A MOFFIT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-09 |
| Decision Date | 2009-07-15 |
| Summary: | summary |