Cleared Special

K110452 - SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,

K110452 is an FDA 510(k) clearance for SOF-FORM II, 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 63-day FDA review.

K110452 · Unilens Corp., USA · Ophthalmic device
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Apr 2011
Decision
63d
Days
Class 2
Risk

K110452 is an FDA 510(k) clearance for the SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO.... 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 April 20, 2011 after a review of 63 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 - K110452

510(k) Number K110452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2011
Decision Date April 20, 2011
Days to Decision 63 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 110d · This submission: 63d
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 K110452.
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS
K110099 · CooperVision, Inc. · Jun 2011
ONE DAY FLAT PACK
K102895 · Menicon Co, Ltd. · Apr 2011
NOVAKONE SPHERICAL AND TORIC LENSES
K102557 · Alden Optical Labs., Inc. · Apr 2011
METRO SOFT
K100244 · Metro Optics of Austin, Inc. · Oct 2010
DEFINITIVE, FLEXLENS - SILICONE HYDROGEL
K100443 · X-Cel Contacts, Inc. · Oct 2010
CVUE ADVANCED DEFINITIVE
K100456 · Unilens Corp., USA · Oct 2010
K110452 · SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
Download PDF Unilens Corp., USA