Cleared Traditional

K123484 - SAVIEW-COLORS 42 UV (HEFILCON A)

K123484 is the FDA 510(k) clearance for SAVIEW-COLORS 42 UV (HEFILCON A) by St. shine Optical Co., Ltd.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

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

K123484 is an FDA 510(k) clearance for the SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A).... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by St. shine Optical Co., Ltd. (Taipei Hsien, TW). The FDA issued a Cleared decision on March 29, 2013 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all St. shine Optical Co., Ltd. devices

Submission Details

510(k) Number K123484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 110d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 161
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K123484.
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
K131208 · Bausch & Lomb, Inc. · Sep 2013
SUS (STENFILCON A) CONTACT LENS
K131378 · CooperVision, Inc. · Aug 2013
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
K123202 · CooperVision, Inc. · May 2013
DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL
K123994 · Ciba Vision Corporation · Feb 2013
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
K122575 · Bausch & Lomb, Inc. · Dec 2012
AVAIRA (ENFILCON A) CONTACT LENS
K113759 · CooperVision, Inc. · Apr 2012