# K982904: Esstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Les Laboratoires Blanchard
- Decided: Sep 1, 1998 after 14 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 P910029/S001 (1993). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964528: (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint, Benz Research and Development Corp. (1997) Summary page 1.
- P910029/S001: Hydron (R) (Polymacon) Hydrophilic Contact Lenses, Les Laboratories Blonchard (1993). A supplement to the PMA, as the summary prints it.

## Most influential descendants
- K070308: Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily Wear (2007), 2 descendants of its own
- 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 ESSTECH® MULTI Aspheric (multifocal) (hioxifilcon B) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and/or presbyopia) in not-aphakic persons with non-diseased eyes. The lens may be worn by persons who may exhibit astigmatism of 1.50 diopters or less that does not interfere with visual acuity. The lens may be disinfected using either heat (thermal) or chemical (not heat) disinfection systems.

Source page: https://510kreport.com/device/K982904
Methodology: https://510kreport.com/methodology