# K020855: Igel 55UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,Igel 55 UV Multifocal (Methafilcon a) Soft

- Pathway: 510(k) (Traditional)
- Applicant: Igel Vision Care Pte, Ltd.
- Decided: Jun 4, 2002 after 81 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 K003526 (2001). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003526: Specialty 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, Specialty 55 UV Multifocal (Methafilcon), Specialty Ultravision, Inc. (2001)

## Most influential descendants
- K030167: Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV Blocker (2003), 6 descendants of its own
- K052290: Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens (2006), 5 descendants of its own
- K080632: CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact Lens (2008), 3 descendants of its own
- K102895: One Day Flat Pack (2011), 1 descendant of its own
- K192129: ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens (2019), 0 descendants of its own

## Indications for use
The Igel 55 UV (methafilcon A) Soft (Hydrophilic) 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 Igel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or not-aphakic persons with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity, in a power range of t4.00 to -5.00 Diopters and have near add requirements up to 3.00 Diopters. The Igel55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 7.00 Diopters. The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. 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 disinfecting systems.

Source page: https://510kreport.com/device/K020855
Methodology: https://510kreport.com/methodology