Cleared Traditional

OMNI Surgical System

K202678 · Sight Sciences, Inc. · Ophthalmic
Mar 2021
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K202678 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 March 1, 2021, 167 days after receiving the submission on September 15, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K202678 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2020
Decision Date March 01, 2021
Days to Decision 167 days
Submission Type Traditional
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