# K963764: Specialty T Toric (Ocufilcon a) Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Ultravision, Inc.
- Decided: Jan 30, 1997 after 133 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hydron Ultra T (ocufilcon A) Toric Soft (Hydrophilic) Contact Lens for Daily Wear: named in the summary without a submission number

## Most influential descendants
- K982110: Polyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Daily Wear (1998), 5 descendants of its own
- K013220: HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully Cast-Molded Lens) (2001), 4 descendants of its own
- K020608: HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully Cast-Molded Lens) (2002), 2 descendants of its own
- K221517: POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens (2022), 1 descendant of its own
- K242855: P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (2025), 0 descendants of its own

## Indications for use
The Specialty T (ocufilcon A) Soft (hydrophilic) Toric Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.50 diopters. Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.

Source page: https://510kreport.com/device/K963764
Methodology: https://510kreport.com/methodology