Cleared Traditional

K100443 - DEFINITIVE, FLEXLENS - SILICONE HYDROGEL

K100443 is an FDA 510(k) clearance for DEFINITIVE, manufactured by X-Cel Contacts, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K100443 · X-Cel Contacts, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Oct 2010
Decision
253d
Days
Class 2
Risk

K100443 is an FDA 510(k) clearance for the DEFINITIVE, FLEXLENS - SILICONE HYDROGEL. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by X-Cel Contacts, Inc. (Grand Junction, US). The FDA issued a Cleared decision on October 28, 2010 after a review of 253 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 X-Cel Contacts, Inc. devices

FDA 510(k) Submission Details - K100443

510(k) Number K100443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2010
Decision Date October 28, 2010
Days to Decision 253 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
143d slower than avg
Panel avg: 110d · This submission: 253d
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 195
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K100443.
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
K111966 · CooperVision, Inc. · Sep 2011
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS
K110099 · CooperVision, Inc. · Jun 2011
ONE DAY FLAT PACK
K102895 · Menicon Co, Ltd. · Apr 2011
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K091339 · CooperVision, Inc. · Jan 2010
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
K083216 · Ciba Vision Corporation · Apr 2009
PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
K081865 · CooperVision, Inc. · Sep 2008