Cleared Traditional

K100221 - INTELLIWAVE3

K100221 is an FDA 510(k) clearance for INTELLIWAVE3, manufactured by Art Optical Contact Lens, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K100221 · Art Optical Contact Lens, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
231d
Days
Class 2
Risk

K100221 is an FDA 510(k) clearance for the INTELLIWAVE3. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Art Optical Contact Lens, Inc. (Grand Junction, US). The FDA issued a Cleared decision on September 14, 2010 after a review of 231 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 Art Optical Contact Lens, Inc. devices

FDA 510(k) Submission Details - K100221

510(k) Number K100221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2010
Decision Date September 14, 2010
Days to Decision 231 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
121d slower than avg
Panel avg: 110d · This submission: 231d
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 444
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K100221.
METRO SOFT
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K100443 · X-Cel Contacts, Inc. · Oct 2010
CVUE ADVANCED DEFINITIVE
K100456 · Unilens Corp., USA · Oct 2010
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K101122 · Benz Research and Development Corp. · Aug 2010
ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES
K091327 · Alden Optical Labs., Inc. · Jun 2010
VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER
K100349 · Johnson & Johnson Vision Care, Inc. · May 2010