Cleared Traditional

K051430 - EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC)

K051430 is an FDA 510(k) clearance for EXTREME H2O 54% (HIOXIFILCON D) SOFT CO..., manufactured by Hydrogel Vision Corporation. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K051430 · Hydrogel Vision Corporation · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
47d
Days
Class 2
Risk

K051430 is an FDA 510(k) clearance for the EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC). Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Hydrogel Vision Corporation (Sarasota, US). The FDA issued a Cleared decision on July 18, 2005 after a review of 47 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K051430

510(k) Number K051430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2005
Decision Date July 18, 2005
Days to Decision 47 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
63d faster than avg
Panel avg: 110d · This submission: 47d
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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K051430.
ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL
K052703 · Alden Optical Labs., Inc. · Nov 2005
55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K051095 · Optical Connection, Inc. · Aug 2005
DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K051129 · Innova Vision, Inc. · Aug 2005
55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K051184 · United Contact Lens, Inc. · Jul 2005
PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
K050948 · Bausch & Lomb, Inc. · May 2005
PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC
K050717 · CooperVision, Inc. · May 2005
K051430 · EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC)
Download PDF FDA Summary Hydrogel Vision Corpo…