Cleared Traditional

K121201 - SAVIE-AQUA 55UV (METHAFILCON A) TINNTED...

K121201 is an FDA 510(k) clearance for SAVIE-AQUA 55UV (METHAFILCON A) TINNTED..., manufactured by St. shine Optical Co., Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 190-day FDA review.

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

FDA 510(k) Submission Details - K121201

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.

LPL Device Classification - Class 2, Special Controls

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 165
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K121201.
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
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BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
K122575 · Bausch & Lomb, Inc. · Dec 2012
BAUSCH + LOMB NESOFILCON A CONTACT LENS
K113703 · Bausch & Lomb, Incorporated · Jun 2012
AVAIRA (ENFILCON A) CONTACT LENS
K113759 · CooperVision, Inc. · Apr 2012
DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
K113168 · Ciba Vision Corporation · Mar 2012