Cleared Traditional

Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens

K180004 · Menicon Co, Ltd. · Ophthalmic
Feb 2018
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K180004 is an FDA 510(k) clearance for the Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Menicon Co, Ltd. (Nagoya, JP). The FDA issued a Cleared decision on February 22, 2018, 51 days after receiving the submission on January 2, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K180004 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2018
Decision Date February 22, 2018
Days to Decision 51 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPL — Lenses, Soft Contact, Daily Wear
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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