The following data is part of a premarket notification filed by Topcon Medical Systems, Inc. with the FDA for Synergy Odm.
| Device ID | K151952 |
| 510k Number | K151952 |
| Device Name: | Synergy ODM |
| Classification | System, Image Management, Ophthalmic |
| Applicant | TOPCON MEDICAL SYSTEMS, INC. 111 BAUER DR Oakland, NJ 07436 |
| Contact | Michael Gusel |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-15 |
| Decision Date | 2015-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852683007049 | K151952 | 000 |
| 00852683007032 | K151952 | 000 |
| 00852683007025 | K151952 | 000 |
| 00852683007018 | K151952 | 000 |
| 00850003069081 | K151952 | 000 |
| 00850003069036 | K151952 | 000 |