Cleared Traditional

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses

K173136 · Menicon Co, Ltd. · Ophthalmic
Nov 2017
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K173136 is an FDA 510(k) clearance for the Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, a Products, Contact Lens Care, Rigid Gas Permeable (Class II — Special Controls, product code MRC), submitted by Menicon Co, Ltd. (Nagoya, JP). The FDA issued a Cleared decision on November 16, 2017, 48 days after receiving the submission on September 29, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5918.

Submission Details

510(k) Number K173136 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2017
Decision Date November 16, 2017
Days to Decision 48 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MRC — Products, Contact Lens Care, Rigid Gas Permeable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5918

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