The following data is part of a premarket notification filed by Sight Sciences, Inc. with the FDA for Viscoelastic Injector.
| Device ID | K132494 |
| 510k Number | K132494 |
| Device Name: | VISCOELASTIC INJECTOR |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | SIGHT SCIENCES, INC. 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Contact | Judy F Gordon D.v.m. |
| Correspondent | Judy F Gordon D.v.m. SIGHT SCIENCES, INC. 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Product Code | MRH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-09 |
| Decision Date | 2013-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858027006013 | K132494 | 000 |