Cleared Traditional

K150630 - Eye Secret 38 UV Aspheric (polymacon) S...

K150630 is an FDA 510(k) clearance for Eye Secret 38 UV Aspheric (polymacon) S..., manufactured by Yung Sheng Optical Co., Ltd.. The device is a Class 2 Ophthalmic device with product code MVN cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K150630 · Yung Sheng Optical Co., Ltd. · Ophthalmic device
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Jun 2015
Decision
96d
Days
Class 2
Risk

K150630 is an FDA 510(k) clearance for the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Dai.... Classified as Lens, Contact, (disposable) (product code MVN), Class II - Special Controls.

Submitted by Yung Sheng Optical Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on June 15, 2015 after a review of 96 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 - K150630

510(k) Number K150630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2015
Decision Date June 15, 2015
Days to Decision 96 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
14d faster than avg
Panel avg: 110d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVN Device Classification - Class 2, Special Controls

Product Code MVN Lens, Contact, (disposable)
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 - MVN Lens, Contact, (disposable)

All 13
Devices cleared under the same product code (MVN) and FDA review panel - the closest regulatory comparables to K150630.
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202448 · Alcon Laboratories, Inc. · Sep 2020
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202036 · Alcon Laboratories, Inc. · Aug 2020
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
K112192 · Bausch & Lomb, Inc. · Oct 2011
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
K080755 · Bausch & Lomb, Inc. · Jun 2008
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
K061948 · CooperVision, Inc. · Nov 2006
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
K050065 · Ciba Vision Corporation · May 2005