Cleared Traditional

K132146 - SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A) (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132146 · St. shine Optical Co., Ltd. · Ophthalmic device

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Aug 2013

Decision

50d

Days

Class 2

Risk

K132146 is an FDA 510(k) clearance for the SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT .... 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 August 30, 2013 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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

Submission Details

510(k) Number	K132146 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 11, 2013
Decision Date	August 30, 2013
Days to Decision	50 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

60d faster than avg

Panel avg: 110d · This submission: 50d

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.