Cleared Traditional

Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses

K192225 · Vizionfocus, Inc. · Ophthalmic
Dec 2019
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K192225 is an FDA 510(k) clearance for the Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Vizionfocus, Inc. (Zhunan Township, TW). The FDA issued a Cleared decision on December 9, 2019, 115 days after receiving the submission on August 16, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K192225 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2019
Decision Date December 09, 2019
Days to Decision 115 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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