Cleared Traditional

K171125 - Tangible Hydrogel w/ Hydra-PEG (etafilc...

K171125 is the FDA 510(k) clearance for Tangible Hydrogel w/ Hydra-PEG (etafilc... by Tangible Science, LLC. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K171125 · Tangible Science, LLC · Ophthalmic device
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Oct 2017
Decision
184d
Days
Class 2
Risk

K171125 is an FDA 510(k) clearance for the Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Co.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Tangible Science, LLC (Menlo Park, US). The FDA issued a Cleared decision on October 18, 2017 after a review of 184 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 Tangible Science, LLC devices

Submission Details

510(k) Number K171125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2017
Decision Date October 18, 2017
Days to Decision 184 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
74d slower than avg
Panel avg: 110d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 161
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K171125.
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
AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal
K172600 · Alcon Laboratories, Inc. · Oct 2017
DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
K172066 · Alcon Laboratories, Inc. · Aug 2017
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
K161391 · Alcon Laboratories, Inc. · Nov 2016
AIR OPTIX COLORS
K162596 · Alcon Laboratories, Inc. · Oct 2016