Cleared Traditional

K161124 - EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear

K161124 is an FDA 510(k) clearance for EYEREVE (hioxifilcon D) Soft (hydrophil..., manufactured by Vision Science Co., Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K161124 · Vision Science Co., Ltd. · Ophthalmic device
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Aug 2016
Decision
127d
Days
Class 2
Risk

K161124 is an FDA 510(k) clearance for the EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Vision Science Co., Ltd. (Gyeongsangbuk-Do, KR). The FDA issued a Cleared decision on August 26, 2016 after a review of 127 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 Vision Science Co., Ltd. devices

FDA 510(k) Submission Details - K161124

510(k) Number K161124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2016
Decision Date August 26, 2016
Days to Decision 127 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
17d slower than avg
Panel avg: 110d · This submission: 127d
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 K161124.
Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens
K162317 · St. shine Optical Co., Ltd. · Oct 2016
AIR OPTIX COLORS
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ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)
K161098 · Joowon Innovation Co., Ltd. · Aug 2016
Hidrocor, Hidrocharme, and Natural Colors
K160472 · Solotica · Aug 2016
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
K160803 · CooperVision, Inc. · Jul 2016