# K100443: Definitive, Flexlens - Silicone Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: X-Cel Contacts, Inc.
- Decided: Oct 28, 2010 after 253 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: 6 generations back to P810005 (1981). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100221: INTELLIWAVE3, Art Optical Contact Lens, Inc. (2010). Cleared while this submission was under review Summary page 2.
- K070308: Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily Wear, X-Cel Contacts (2007) Summary page 2.
- K052560: Biofinity (Comfilcon a) Soft Contact Lens, CooperVision, Inc. (2005) Summary page 2.
- K983637: Actifresh 400 Lens, Hydron, Ltd. (1999) Summary page 2.

## Most influential descendants
- K242059: Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) (2024), 0 descendants of its own

## Indications for use
The Definitive, Flexiens, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wea are indicated for the correction of arretropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The Definitive, Flexiens, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wea are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters. The Definitive, Flexiens, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wea are indicated for the correction of arnetropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters. The Definitive, Flexiens, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The Definitive, Flexiens, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of armetropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular comneal conditions such as keratoconus and post graft fitting Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

Source page: https://510kreport.com/device/K100443
Methodology: https://510kreport.com/methodology