Cleared Traditional

VISCOELASTIC INJECTOR

K132494 · Sight Sciences, Inc. · Ophthalmic

Oct 2013

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K132494 is an FDA 510(k) clearance for the VISCOELASTIC INJECTOR, a Pump, Infusion, Ophthalmic (Class II — Special Controls, product code MRH), submitted by Sight Sciences, Inc. (Laguna Beach, US). The FDA issued a Cleared decision on October 22, 2013, 74 days after receiving the submission on August 9, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K132494 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 2013
Decision Date	October 22, 2013
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF