Cleared Traditional

K133735 - EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS

K133735 is an FDA 510(k) clearance for EYE SECRET 55 UV ASPHERIC (METHAFILCON ..., manufactured by Yung Sheng Optical Co., Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K133735 · Yung Sheng Optical Co., Ltd. · Ophthalmic device
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Mar 2014
Decision
102d
Days
Class 2
Risk

K133735 is an FDA 510(k) clearance for the EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Yung Sheng Optical Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on March 21, 2014 after a review of 102 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 Yung Sheng Optical Co., Ltd. devices

FDA 510(k) Submission Details - K133735

510(k) Number K133735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2013
Decision Date March 21, 2014
Days to Decision 102 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 110d · This submission: 102d
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 444
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K133735.
ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
K141670 · Johnson & Johnson Vision Care, Inc. · Sep 2014
ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
K141280 · Seinoh Optical Co. , Ltd. · Jul 2014
FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS
K133403 · Firestone Optics, Inc. · Jun 2014
ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED)
K132714 · Vision Science Co., Ltd. · Mar 2014
SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT
K133740 · Sauflon Pharmaceuticals, Ltd. · Mar 2014
SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
K133472 · Souflon Pharmaceuticals, Ltd. · Mar 2014