510(k) K232214
K232214 is an FDA 510(k) premarket notification submitted by Sight Sciences, Inc. for the device "OMNI Surgical System". The FDA issued a decision of Substantially Equivalent on August 25, 2023. The device falls under product code MRH (Pump, Infusion, Ophthalmic), a Class II device regulated under 21 CFR 880.5725. Sight Sciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2023
- Date Received
- July 26, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- OP
- Submission Type