Cleared Special

OMNI PLUS Surgical System

K201953 · Sight Sciences, Inc. · Ophthalmic
Aug 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K201953 is an FDA 510(k) clearance for the OMNI PLUS 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 11, 2020, 28 days after receiving the submission on July 14, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K201953 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2020
Decision Date August 11, 2020
Days to Decision 28 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