Cleared Special

K082393 - CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

K082393 is an FDA 510(k) clearance for CVUE ADVANCED (HIOXIFILCON D) SOFT (HYD..., manufactured by Unilens Corp., USA. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Special 510(k) pathway after a 23-day FDA review.

K082393 · Unilens Corp., USA · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
23d
Days
Class 2
Risk

K082393 is an FDA 510(k) clearance for the CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Unilens Corp., USA (Largo, US). The FDA issued a Cleared decision on September 11, 2008 after a review of 23 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K082393

510(k) Number K082393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2008
Decision Date September 11, 2008
Days to Decision 23 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
87d faster than avg
Panel avg: 110d · This submission: 23d
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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K082393.
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
PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
K081865 · CooperVision, Inc. · 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
WESTCON HORIZON 49% (HIOXIFILCON B)
K080686 · Westcon Contact Lens Co. · Apr 2008
K082393 · CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
Download PDF FDA Summary Unilens Corp., USA