Cleared Traditional

K110099 - PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS

Also marketed or referenced as:
PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS PROCLEAR MULT

K110099 is an FDA 510(k) clearance for PROCLEAR TORIC XR SOFT (HYDROPHILIC) CO..., manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K110099 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
167d
Days
Class 2
Risk

K110099 is an FDA 510(k) clearance for the PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by CooperVision, Inc. (Pleasanton, US). The FDA issued a Cleared decision on June 29, 2011 after a review of 167 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 CooperVision, Inc. devices

FDA 510(k) Submission Details - K110099

510(k) Number K110099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2011
Decision Date June 29, 2011
Days to Decision 167 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
57d slower than avg
Panel avg: 110d · This submission: 167d
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 291
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K110099.
SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS
K111345 · The See Clear Company, Inc. · Nov 2011
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
K111966 · CooperVision, Inc. · Sep 2011
ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS
K110261 · Soflex Limited · Jul 2011
ONE DAY FLAT PACK
K102895 · Menicon Co, Ltd. · Apr 2011
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
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K091339 · CooperVision, Inc. · Jan 2010