The following data is part of a premarket notification filed by Sight Sciences, Inc. with the FDA for Omni Plus Surgical System.
| Device ID | K201953 |
| 510k Number | K201953 |
| Device Name: | OMNI PLUS Surgical System |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | Sight Sciences, Inc. 4040 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-14 |
| Decision Date | 2020-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858027006358 | K201953 | 000 |