Cleared Traditional

One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens

K180819 · Menicon Co, Ltd. · Ophthalmic
May 2018
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K180819 is an FDA 510(k) clearance for the One Day Flat Pack (hioxifilcon A) Daily Disposable 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 May 16, 2018, 48 days after receiving the submission on March 29, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K180819 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2018
Decision Date May 16, 2018
Days to Decision 48 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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