Cleared Special

K110452 - SOF-FORM II

K110452 is the FDA 510(k) clearance for SOF-FORM II by Unilens Corp., USA. It is a Class 2 Ophthalmic device (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.

View all Unilens Corp., USA devices

Submission Details

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
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 110d · This submission: 63d
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.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 140
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