# K020389: Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Ocular Sciences
- Decided: Jun 4, 2002 after 119 days
- Product code: MVN (Lens, Contact, (Disposable))
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003136 (2001). 1 ancestor in all.
22 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003136: Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily Wear Soft Contact Lens, Ocular Sciences Puerto Rico, Inc. (2001)

## Most influential descendants
- K131378: Sus (Stenfilcon a) Contact Lens (2013), 10 descendants of its own
- K061948: Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens (2006), 9 descendants of its own
- K110099: Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft (Hydrophilic) Contact Lens; Proclear Mult (2011), 7 descendants of its own
- K112302: Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere & Asphere, Toric Contact Lenses (2011), 6 descendants of its own
- K162223: Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) (2017), 4 descendants of its own

## Indications for use
Spherical: BIOMEDICSB 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters that does not interfere with visual acuity. Toric: BIOMEDICSB 52 1-Day (ocufilcon B) Soft (Hydrophi1ic)UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 10.00 diopters. The lens may be prescribed for Daily Wear in not- aphakic persons. The eyecare practitioner may prescribe the contact lens for single use disposable wear. The BIOMEDICSB 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Source page: https://510kreport.com/device/K020389
Methodology: https://510kreport.com/methodology