Cleared Traditional

K100456 - CVUE ADVANCED DEFINITIVE

K100456 is an FDA 510(k) clearance for CVUE ADVANCED DEFINITIVE, manufactured by Unilens Corp., USA. 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.

K100456 · Unilens Corp., USA · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
253d
Days
Class 2
Risk

K100456 is an FDA 510(k) clearance for the CVUE ADVANCED DEFINITIVE. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Unilens Corp., USA (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.

FDA 510(k) Submission Details - K100456

510(k) Number K100456 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
Combination Product No
PCCP Authorized No
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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K100456.
SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
K110452 · Unilens Corp., USA · Apr 2011
METRO SOFT
K100244 · Metro Optics of Austin, Inc. · Oct 2010
DEFINITIVE, FLEXLENS - SILICONE HYDROGEL
K100443 · X-Cel Contacts, Inc. · Oct 2010
INTELLIWAVE3
K100221 · Art Optical Contact Lens, Inc. · Sep 2010
BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS
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
K100456 · CVUE ADVANCED DEFINITIVE
Download PDF FDA Summary Unilens Corp., USA