# K113267: BIOPMEDICS52,52 1DAY,52 Toric,52 1DAY Toric

- Pathway: 510(k) (Special)
- Applicant: CooperVision, Inc.
- Decided: Dec 2, 2011 after 28 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- 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: 2 generations back to K003136 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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) Summary page 3.
- K020389: Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens, Ocular Sciences (2002) Summary page 3.

## Indications for use
SPHERICAL Biomedics 52 (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 Biomedics 52 (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 10.00 diopters. The lens may be prescribed for Daily Wear in not-aphakic persons. The eyecare practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear the lens is to be discarded after each removal. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system. The Biomedics (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/K113267
Methodology: https://510kreport.com/methodology