Cleared Special

K112176 - SILICONE SPHERES
(FDA 510(k) Clearance)

K112176 · Oculo Plastik, Inc. · Ophthalmic
Sep 2011
Decision
49d
Days
Class 2
Risk

K112176 is an FDA 510(k) clearance for the SILICONE SPHERES, a Implant, Eye Sphere (Class II — Special Controls, product code HPZ), submitted by Oculo Plastik, Inc. (Montreal, Quebec, CA). The FDA issued a Cleared decision on September 15, 2011, 49 days after receiving the submission on July 28, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3320.

Submission Details

510(k) Number K112176 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2011
Decision Date September 15, 2011
Days to Decision 49 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HPZ — Implant, Eye Sphere
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.3320