The following data is part of a premarket notification filed by Sight Sciences, Inc. with the FDA for Omni Surgical System.
| Device ID | K202678 |
| 510k Number | K202678 |
| Device Name: | OMNI Surgical System |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | Sight Sciences, Inc. 440 Campbell Ave, Suite 100 Menlo Park, CA 94025 |
| Contact | Edward J. Sinclair |
| Correspondent | Edward J. Sinclair Sight Sciences, Inc. 4040 Campbell Ave, Suite 100 Menlo Park, CA 94025 |
| Product Code | MRH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-15 |
| Decision Date | 2021-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858027006525 | K202678 | 000 |