Cleared Special

K123202 - PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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

Regulatory Context

Review time vs. panel average

120d slower than avg

Panel avg: 110d · This submission: 230d

Pathway characteristics

Modification to existing cleared device.

Device Classification

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.