# K984046: Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens

- Pathway: 510(k) (Traditional)
- Applicant: Ocular Sciences Puerto Rico, Inc.
- Decided: Jan 21, 1999 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: 2 generations back to K942214 (1994). 3 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K020193: Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact Lens (2002), 11 descendants of its own
- K012425: Biomedics UV Multifocal (2001), 10 descendants of its own
- K091339: Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens (2010), 9 descendants of its own
- K013377: Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens (2001), 4 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

## Indications for use
The BIOMEDICS® 55 (ocufilcon D) UV Blocking soft (hydrophilic) contact lens is indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or frequent replacement scheduled program. The lenses may be prescribed for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Frequent Replacement Program, as recommended by the eyecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.

Source page: https://510kreport.com/device/K984046
Methodology: https://510kreport.com/methodology