Cleared Traditional

K121201 - SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS (FDA 510(k) Clearance)

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

K121201 · St. shine Optical Co., Ltd. · Ophthalmic device

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Oct 2012

Decision

190d

Days

Class 2

Risk

K121201 is an FDA 510(k) clearance for the SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by St. shine Optical Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on October 26, 2012 after a review of 190 days - an extended review 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: 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	K121201 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 19, 2012
Decision Date	October 26, 2012
Days to Decision	190 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

80d slower than avg

Panel avg: 110d · This submission: 190d

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.