Cleared Traditional

K040303 - 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS

K040303 is an FDA 510(k) clearance for 59% EXTREME H2O (HIOXIFILCON A) 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 359-day FDA review.

K040303 · Hydrogel Vision Corporation · Ophthalmic device
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Feb 2005
Decision
359d
Days
Class 2
Risk

K040303 is an FDA 510(k) clearance for the 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS. 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 February 2, 2005 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Hydrogel Vision Corporation devices

FDA 510(k) Submission Details - K040303

510(k) Number K040303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2004
Decision Date February 02, 2005
Days to Decision 359 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
249d slower than avg
Panel avg: 110d · This submission: 359d
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 287
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K040303.
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
MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS
K050157 · Bausch & Lomb, Inc. · Apr 2005
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K042824 · CooperVision, Inc. · Nov 2004
COOPER PROSTHETIC
K042435 · CooperVision, Inc. · Oct 2004
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
K041138 · CooperVision, Inc. · Jul 2004