Cleared Traditional

Endocular Viewing Lenses and Silicone Ring

K173944 · Phakos · Ophthalmic
Oct 2018
Decision
303d
Days
Class 2
Risk

About This 510(k) Submission

K173944 is an FDA 510(k) clearance for the Endocular Viewing Lenses and Silicone Ring, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Phakos (Montreuil, FR). The FDA issued a Cleared decision on October 25, 2018, 303 days after receiving the submission on December 26, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K173944 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2017
Decision Date October 25, 2018
Days to Decision 303 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HJK — Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1385

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