Cleared Traditional

SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS

K123484 · St. shine Optical Co., Ltd. · Ophthalmic
Mar 2013
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K123484 is an FDA 510(k) clearance for the SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by St. shine Optical Co., Ltd. (Taipei Hsien, TW). The FDA issued a Cleared decision on March 29, 2013, 136 days after receiving the submission on November 13, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K123484 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2012
Decision Date March 29, 2013
Days to Decision 136 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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