# K031477: Hydrogenics 2.0 60 UV Asphere (Ocufilcon F) Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Abbreviated)
- Applicant: Ocular Sciences, Inc.
- Decided: Jul 18, 2003 after 70 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: 4 generations back to K942214 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992264: Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily Wear Soft Contact Lens, Ocular Sciences Puerto Rico, Inc. (1999) Summary page 1.
- K020193: Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact Lens, Cl Mcintosh (2002)

## Indications for use
HYDROGENICSB 2.0 60 U V ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact lenses are indicated for the correction of visual acuity in persons with not-aphakic. non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism 2.00 diopters or less that does riot interfere with visual acuity. The HYDROGENICB 3.0 60 UV ASPHERE (ocufilcon F) Soft (H>drophilic) Contact Lenses are indicated for daily wear. The eye care practitioner may prescribe the contact lenses for either single use disposable wear or for frequent replacement wear. When prescribed for frequent replacement planned replacement the lenses may be disinfected using a chemical or hydrogen peroxide disinfecting s>stcnis The HYDROGENICSB 2.0 60 UV ASPHERE (ocufilcon F) Soft (H\,drophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Source page: https://510kreport.com/device/K031477
Methodology: https://510kreport.com/methodology