Cleared Traditional

K142820 - BIOLENS Sphere (mangofilcon A) Soft (hy...

K142820 is the FDA 510(k) clearance for BIOLENS Sphere (mangofilcon A) Soft (hy... by Abb Optical Group, LLC. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K142820 · Abb Optical Group, LLC · Ophthalmic device
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Apr 2015
Decision
212d
Days
Class 2
Risk

K142820 is an FDA 510(k) clearance for the BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Abb Optical Group, LLC (Alameda, US). The FDA issued a Cleared decision on April 30, 2015 after a review of 212 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Abb Optical Group, LLC devices

Submission Details

510(k) Number K142820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2014
Decision Date April 30, 2015
Days to Decision 212 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 110d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 161
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AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
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K131208 · Bausch & Lomb, Inc. · Sep 2013