BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear— 510(k) K142820

Name: FDA 510(k) clearance K142820
Creator: U.S. Food and Drug Administration
Published: 2015-04-30

Substantially Equivalent

Abb Optical Group, LLC

FDA 510(k) clearance K142820 for BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, Substantially Equivalent on 2015-04-30. Applicant: Abb Optical Group, LLC. Device class: 2.

Clearance details

Applicant: Abb Optical Group, LLC
Product code: Code LPL
Device class: Class 2
Regulation: 21 CFR 886.5925
Advisory panel: Ophthalmic
Date received: 2014-09-30
Decision date: 2015-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

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Recent devices under product code LPL

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Adverse events under product code LPL

product code LPL

Injury: 988
Other: 4
Total: 992

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.