The following data is part of a premarket notification filed by Sight Sciences, Inc. with the FDA for Omni Surgical System.
| Device ID | K173332 |
| 510k Number | K173332 |
| Device Name: | OMNI Surgical System |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | Sight Sciences, Inc. 3000 Sand Hill Road Building 3, Suite 105 Menlo Park, CA 94025 |
| Contact | Anne-marie Ripley |
| Correspondent | Anne-marie Ripley Sight Sciences, Inc. 3000 Sand Hill Road Building 3, Suite 105 Menlo Park, CA 94025 |
| Product Code | MRH |
| Subsequent Product Code | GAR |
| Subsequent Product Code | GAW |
| Subsequent Product Code | HMX |
| Subsequent Product Code | HMZ |
| Subsequent Product Code | HNN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-23 |
| Decision Date | 2017-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858027006310 | K173332 | 000 |
| 00858027006334 | K173332 | 000 |