Cleared Special

OMNI Surgical System

K232214 · Sight Sciences, Inc. · Ophthalmic
Aug 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K232214 is an FDA 510(k) clearance for the OMNI Surgical System, a Pump, Infusion, Ophthalmic (Class II — Special Controls, product code MRH), submitted by Sight Sciences, Inc. (Menlo Park, US). The FDA issued a Cleared decision on August 25, 2023, 30 days after receiving the submission on July 26, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K232214 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2023
Decision Date August 25, 2023
Days to Decision 30 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MRH — Pump, Infusion, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725