Cleared Traditional

K151847 - SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens

K151847 is an FDA 510(k) clearance for SMART PERFORMER (Polymacon) Soft (Hydro..., manufactured by Smart Performer Corp. , Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K151847 · Smart Performer Corp. , Ltd. · Ophthalmic device
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Mar 2016
Decision
241d
Days
Class 2
Risk

K151847 is an FDA 510(k) clearance for the SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Smart Performer Corp. , Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on March 4, 2016 after a review of 241 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 Smart Performer Corp. , Ltd. devices

FDA 510(k) Submission Details - K151847

510(k) Number K151847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2015
Decision Date March 04, 2016
Days to Decision 241 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
131d slower than avg
Panel avg: 110d · This submission: 241d
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 350
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K151847.
EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear
K153305 · Eyeyon Medical · Apr 2016
Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
K153766 · INTEROJO, Inc. · Apr 2016
ACUVUE (senofilcon C) Soft Contact Lens
K160212 · Johnson & Johnson Vision Care, Inc. · Mar 2016
Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist
K151918 · Bausch & Lomb, Incorporated · Feb 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
K153642 · Alcon Laboratories, Inc. · Jan 2016
Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
K153643 · Alcon Laboratories, Inc. · Jan 2016