# K101122: Benz-G 4X (Hioxifilcon D) Multifocal Lathed Lens

- Pathway: 510(k) (Traditional)
- Applicant: Benz Research and Development Corp.
- Decided: Aug 9, 2010 after 110 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: 3 generations back to K992692 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062854: Benz-G 4X Hioxifilcon D, Benz Research and Development Corp. (2007) Summary page 1.

## Indications for use
The Benz-G 4X 54% (Hioxifilcon D) Multifocal Lathed soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are myopic, hyperopic, possess astigmatism of 10.0 diopters or less and are presbyopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopter or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10 Diopters. Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K101122
Methodology: https://510kreport.com/methodology