The following data is part of a premarket notification filed by Optimedica Corporation with the FDA for Optimedica Laser Indirect Ophthalmoscope.
| Device ID | K062336 |
| 510k Number | K062336 |
| Device Name: | OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE |
| 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 | 2006-08-10 |
| Decision Date | 2006-10-19 |
| Summary: | summary |