# K992264: Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily Wear Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Ocular Sciences Puerto Rico, Inc.
- Decided: Nov 24, 1999 after 141 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: 3 generations back to K942214 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984046: Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens, Ocular Sciences Puerto Rico, Inc. (1999) Summary page 1.
- K942214: H55 Hydrophilic Contact Lens, Martin S. Knopf Assoc., Inc. (1994) Summary page 1.
- K972303: Oscular Sciences/ American Hydron, Inc  Daily Wear Soft Contact Lens, Ocular Sciences Puerto Rico, Inc. (1997) Summary page 1.
- P890023: H55 Hydrophilic Contact Lens, The Cooper Companies (1989) Summary page 1.

## Most influential descendants
- K031477: Hydrogenics 2.0 60 UV Asphere (Ocufilcon F) Soft (Hydrophilic) Contact Lens (2003), 0 descendants of its own

## Indications for use
Spherical: Biomedics® 60 (ocufilcon F) 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 up to 2.00 diopters that does not interfere with visual acuity. Toric: Biomedics® 60 (ocufilcon F) 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 up to 10.00 diopters. The lenses may be prescribed for Daily Wear in not-aphakic persons. The eye care practitioner may prescribe the contact lens for either single use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement (SEE WEARING SCHEDULE). When prescribing for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system. Biomedics® 60 (ocufilcon F) 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/K992264
Methodology: https://510kreport.com/methodology