Cleared Traditional

K153305 - EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear

K153305 is an FDA 510(k) clearance for EyeYon (hioxirilcon D) Soft (hydrophill..., manufactured by Eyeyon Medical. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K153305 · Eyeyon Medical · Ophthalmic device
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Apr 2016
Decision
144d
Days
Class 2
Risk

K153305 is an FDA 510(k) clearance for the EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Eyeyon Medical (Nes Ziona, IL). The FDA issued a Cleared decision on April 8, 2016 after a review of 144 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 Eyeyon Medical devices

FDA 510(k) Submission Details - K153305

510(k) Number K153305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2015
Decision Date April 08, 2016
Days to Decision 144 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
34d slower than avg
Panel avg: 110d · This submission: 144d
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 Consultant

Eyereg Consulting, Inc.
BRET ANDRE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K153305.
Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016
K160344 · Visco Vision, Inc. · May 2016
SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens
K152657 · Smart Performer Corp. , Ltd. · May 2016
AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric
K160609 · Alcon Laboratories, Inc. · May 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
SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens
K151847 · Smart Performer Corp. , Ltd. · Mar 2016