Cleared Special

K081865 - PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR

K081865 is an FDA 510(k) clearance for PROCLEAR MULTIFOCAL TORIC AND XR AND TO..., 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 90-day FDA review.

K081865 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
90d
Days
Class 2
Risk

K081865 is an FDA 510(k) clearance for the PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by CooperVision, Inc. (Scottsville,, US). The FDA issued a Cleared decision on September 29, 2008 after a review of 90 days - within the typical 510(k) review window.

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 - K081865

510(k) Number K081865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2008
Decision Date September 29, 2008
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
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 K081865.
EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
K082883 · I-See Vision Technology, Inc. · Jun 2009
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
K083216 · Ciba Vision Corporation · Apr 2009
POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K080794 · Polyvue Distribution, Inc. · Dec 2008
CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K082393 · Unilens Corp., USA · Sep 2008
REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
K080512 · Metro Optics of Austin, Inc. · Jul 2008
INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
K073621 · Art Optical Contact Lens, Inc. · Jul 2008
K081865 · PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
Download PDF FDA Summary CooperVision, Inc.