# K984090: Speciality 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear, Speciality 55 (Methafilcon a)

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Ultravision, Inc.
- Decided: Jul 7, 1999 after 233 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 K963488 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963488: Specialty Progressive (Methafilcon a)Multifocal Soft (Hydrophilic)Contact Lens for Daily Wear (Clear and Tinted), Specialty Ultravision, Inc. (1996) Summary page 2.
- K974837: Igel (R) 56 (Hefilcon C) Soft (Hydrophlic) Contact Lens, Igel Vision Care Pte, Ltd. (1998) Summary page 2.

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

## Indications for use
The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia 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 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/K984090
Methodology: https://510kreport.com/methodology