PASCAL SYNTHESIS DELIVERY SYSTEM
Powered Laser Surgical Instrument
OPTIMEDICA CORPORATION
The following data is part of a premarket notification filed by Optimedica Corporation with the FDA for Pascal Synthesis Delivery System.
Pre-market Notification Details
| Device ID | K081744 |
| 510k Number | K081744 |
| Device Name: | PASCAL SYNTHESIS DELIVERY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OPTIMEDICA CORPORATION 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon OPTIMEDICA CORPORATION 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-19 |
| Decision Date | 2008-09-09 |
| Summary: | summary |
Trademark Results [PASCAL SYNTHESIS DELIVERY SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PASCAL SYNTHESIS DELIVERY SYSTEM 77494240 not registered Dead/Abandoned |
OptiMedica Corporation 2008-06-09 |
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