Cleared Special

VISCO 360 Viscosurgical System

K171905 · Sight Sciences, Inc. · Ophthalmic

Jul 2017

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K171905 is an FDA 510(k) clearance for the VISCO 360 Viscosurgical 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 July 27, 2017, 31 days after receiving the submission on June 26, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K171905 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2017
Decision Date	July 27, 2017
Days to Decision	31 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF