# K963488: Specialty Progressive (Methafilcon a)Multifocal Soft (Hydrophilic)Contact Lens for Daily Wear (Clear and Tinted)

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Ultravision, Inc.
- Decided: Nov 20, 1996 after 78 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) LifeStyle FREQUENCY PROGRESSIVE (methafilcon A) Multifocal Soft (Hydrophilic) Contact Lens for Daily Wear (clear and tinted): named in the summary without a submission number
- (no number) LifeStyle 55 (methafilcon A) Single Vision Soft (Hydrophilic) Contact Lens for Daily Wear (clear and tinted): named in the summary without a submission number

## Most influential descendants
- K984090: Speciality 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear, Speciality 55 (Methafilcon a) (1999), 1 descendant of its own
- K993580: Specialty 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear (2000), 0 descendants of its own

## Indications for use
The Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. Eyecare practitioners may prascribe the lans for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfaection systems. The Specialty Choice*® (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens is indicated for daily wear for the correction of refractive ametrapia (myopid and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

Source page: https://510kreport.com/device/K963488
Methodology: https://510kreport.com/methodology