Cleared Traditional

K171447 - OxyPure Color Silicone Hydrogel Soft Contact Lenses

K171447 is an FDA 510(k) clearance for OxyPure Color Silicone Hydrogel Soft Co..., manufactured by Visco Vision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K171447 · Visco Vision, Inc. · Ophthalmic device
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Dec 2017
Decision
203d
Days
Class 2
Risk

K171447 is an FDA 510(k) clearance for the OxyPure Color Silicone Hydrogel Soft Contact Lenses. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Visco Vision, Inc. (Taoyuan City, TW). The FDA issued a Cleared decision on December 5, 2017 after a review of 203 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 Visco Vision, Inc. devices

FDA 510(k) Submission Details - K171447

510(k) Number K171447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2017
Decision Date December 05, 2017
Days to Decision 203 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
93d slower than avg
Panel avg: 110d · This submission: 203d
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 349
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K171447.
OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens
K173958 · Visco Vision, Inc. · Apr 2018
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
K180004 · Menicon Co, Ltd. · Feb 2018
Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens
K172692 · Tangible Science, LLC · Dec 2017
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
K173086 · Visioneering Technologies, Inc. · Nov 2017
AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal
K172600 · Alcon Laboratories, Inc. · Oct 2017
Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
K171125 · Tangible Science, LLC · Oct 2017