Cleared Traditional

K062541 - CALAVIEW COLORS (ETAFILCON A) SOFT (HYD...

K062541 is an FDA 510(k) clearance for CALAVIEW COLORS (ETAFILCON A) SOFT (HYD..., manufactured by Innova Vision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K062541 · Innova Vision, Inc. · Ophthalmic device
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Jun 2007
Decision
281d
Days
Class 2
Risk

K062541 is an FDA 510(k) clearance for the CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Innova Vision, Inc. (Flagstaff, US). The FDA issued a Cleared decision on June 7, 2007 after a review of 281 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 Innova Vision, Inc. devices

FDA 510(k) Submission Details - K062541

510(k) Number K062541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2006
Decision Date June 07, 2007
Days to Decision 281 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
171d slower than avg
Panel avg: 110d · This submission: 281d
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 165
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K062541.
CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES
K073459 · Ciba Vision Corporation · Feb 2008
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
K072777 · Ciba Vision Corporation · Jan 2008
AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
K071736 · CooperVision, Inc. · Jan 2008
CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS
K062262 · Ciba Vision Corporation · Nov 2006
BIOFINITY (COMFILCON A) SOFT CONTACT LENS
K052560 · CooperVision, Inc. · Dec 2005
PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
K050948 · Bausch & Lomb, Inc. · May 2005