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
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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.

View all CooperVision, Inc. devices

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 348
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