# K972303: Oscular Sciences/ American Hydron, Inc  Daily Wear Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Ocular Sciences Puerto Rico, Inc.
- Decided: Aug 20, 1997 after 62 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: 1 generation back to K942214 (1994). 1 ancestor in all.
21 later devices descend from it; 5 cite it directly.
0 of 23 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.

## Most influential descendants
- K984046: Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens (1999), 15 descendants of its own
- K982947: Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact Lens (1999), 13 descendants of its own
- 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

## Indications for use
The Hydron Biomedics 55 (ocufilcon D) visibility tint soft (hydrophilic) contact lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit astigmatism of 2.00 D or less that does not interfere with visual acuity; it is available in powers from -10 to + 10 diopters. Eyecare practitioners may prescribe the lens for either single-use disposable wear or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement (see WEARING SCHEDULE). When prescribed for frequent/ planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K972303
Methodology: https://510kreport.com/methodology