# K993580: Specialty 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Ultravision, Inc.
- Decided: Feb 2, 2000 after 103 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 K963488 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984090: Speciality 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear, Speciality 55 (Methafilcon a), Specialty Ultravision, Inc. (1999) Summary page 1.

## Indications for use
The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

Source page: https://510kreport.com/device/K993580
Methodology: https://510kreport.com/methodology