Medical Device Manufacturer · US , Alameda , CA

Abb Optical Group, LLC - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2015

Recent clearances: 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

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Abb Optical Group, LLC Ophthalmic ✕

1 devices

1-1 of 1

Cleared Apr 30, 2015

BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily...

Ophthalmic · 212d

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: Sep 21, 2026