# K012425: Biomedics UV Multifocal

- Pathway: 510(k) (Traditional)
- Applicant: Ocular Sciences Puerto Rico, Inc.
- Decided: Oct 12, 2001 after 74 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). 5 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 16 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.
- K003170: Rythmic and Rythmic UV, Essilor Intl. (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 Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. The eye care practitioner may prescribe the contact lens for either single use disposable wear and or for frequent replacement wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system. BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are presbyopic, with or without associated ametropia. The lens may be worn by persons who require up to +3.00 diopters of addition and who exhibit refractive astigmatism of 0.75 diopters or less that does a0t interfere with visual acuity. The BIOMEDICS® UV Multifocal (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/K012425
Methodology: https://510kreport.com/methodology