Cleared Special

K123202 - PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS

K123202 is an FDA 510(k) clearance for PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC..., manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Special 510(k) pathway after a 230-day FDA review.

K123202 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
230d
Days
Class 2
Risk

K123202 is an FDA 510(k) clearance for the PROCLEAR (OMAFILCON A) 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 May 30, 2013 after a review of 230 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K123202

510(k) Number K123202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2012
Decision Date May 30, 2013
Days to Decision 230 days
Submission Type Special
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
120d slower than avg
Panel avg: 110d · This submission: 230d
Pathway characteristics
Modification to existing cleared device.

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 489
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K123202.
SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)
K132146 · St. shine Optical Co., Ltd. · Aug 2013
SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
K130342 · Sauflon Pharmaceuticals, Ltd. · Aug 2013
DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D
K123431 · Dreamcon Co., Ltd. · Jun 2013
LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE
K120756 · The Lagado Corp. · May 2013
AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
K123973 · Pegavision Corporation · Apr 2013
SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS
K123484 · St. shine Optical Co., Ltd. · Mar 2013
K123202 · PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
Download PDF FDA Summary CooperVision, Inc.