Last synced on 14 November 2025 at 11:06 pm

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

Page Type
Cleared 510(K)
510(k) Number
K142820
510(k) Type
Traditional
Applicant
ABB Optical Group, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/30/2015
Days to Decision
212 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
510(k) Number
K142820
510(k) Type
Traditional
Applicant
ABB Optical Group, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/30/2015
Days to Decision
212 days
Submission Type
Summary