Cleared Traditional

Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear

K223585 · Yung Sheng Optical Co., Ltd. · Ophthalmic
Dec 2023
Decision
384d
Days
Class 2
Risk

About This 510(k) Submission

K223585 is an FDA 510(k) clearance for the Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Yung Sheng Optical Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on December 20, 2023, 384 days after receiving the submission on December 1, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K223585 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2022
Decision Date December 20, 2023
Days to Decision 384 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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