Cleared Traditional

OMNI Surgical System

K173332 · Sight Sciences, Inc. · Ophthalmic

Dec 2017

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K173332 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 December 21, 2017, 59 days after receiving the submission on October 23, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K173332 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 23, 2017
Decision Date	December 21, 2017
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF