# K020193: Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Abbreviated)
- Applicant: Cl Mcintosh
- Decided: Feb 28, 2002 after 41 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). 6 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P890023: H55 Hydrophilic Contact Lens, The Cooper Companies (1989) Summary page 2.
- K984046: Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens, Ocular Sciences Puerto Rico, Inc. (1999) Summary page 1.
- K982947: Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact Lens, Ocular Sciences Puerto Rico, Inc. (1999) Summary page 1.
- K000384: Frequency 55, Frequency 55 Aspheric, Encore, Encore Toric, Oneview, Cooperflex, CooperVision, Inc. (2000) Summary page 2.

## Most influential descendants
- K091339: Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens (2010), 9 descendants of its own
- K181232: Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (2018), 3 descendants of its own
- K182523: Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (2018), 2 descendants of its own
- K182247: ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) (2018), 2 descendants of its own
- K141280: Ilens (Ocufilcon D) Daily Soft Contact Lens (2014), 1 descendant of its own

## Indications for use
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-aphakic, non-diseased eyes which manifest myopia (nearsightedness), hyperopia (farsightedness) and astigmatic correction lower than -2.00 diopters that does not interfere with visual acuity. The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses may be prescribed for daily wear. The eye-care practitioner may prescribe the BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) contact lenses for single use disposable wear or for scheduled replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for scheduled replacement the lens may be disinfected using chemical (not heat) or hydrogen peroxide disinfecting systems. The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Source page: https://510kreport.com/device/K020193
Methodology: https://510kreport.com/methodology