# K070308: Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: X-Cel Contacts
- Decided: Mar 12, 2007 after 39 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: 4 generations back to K954524 (1996). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043129: Proclear Ultravue Multifocal and Proclear Ultravue 2000T Multifocal Toric (Omaflicon a) Soft (Hydrophilic Contact Lens), Opti-Centre Laboratories (2005) Summary page 1.
- K043540: Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact Lenses, Westcon Contact Lens Co., Inc. (2005) Summary page 1.
- K982904: Esstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft (Hydrophilic) Contact Lens, Les Laboratoires Blanchard (1998) Summary page 1.

## Most influential descendants
- K100443: Definitive, Flexlens - Silicone Hydrogel (2010), 1 descendant of its own
- K242059: Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) (2024), 0 descendants of its own

## Indications for use
The Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear is indicated for daily wear use for the correction of refractive ametropia (myopia, hyperopia and/or presbyopia) in non-aphakic persons

Source page: https://510kreport.com/device/K070308
Methodology: https://510kreport.com/methodology