# K972807: (Lenses)Benz Hefilcon a Spherical/Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue or Light Green Visibi

- Pathway: 510(k) (Traditional)
- Applicant: Benz Research and Development Corp.
- Decided: Oct 15, 1997 after 79 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The BENZ hefilcon A SPHERICAL Soft (Hydrophilic) Contact Lenses in clear or with a light blue or light green visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The spherical lenses are available from +20.00 to -20.00 Diopters and may be worn by patients who can accomodate up to 1.5 Diopters of astigmatism. The BENZ hefilcon A TORIC Soft (Hydrophilic) Contact Lenses in clear or with a light blue or light green visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The Toric lenses are available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction where it does not interefere with visual acuity. The BENZ hefilcon A Spherical and Toric Contact lenses may be disinfected using either the heat (thermal) or the chemical (non-heat) disinfection system.

Source page: https://510kreport.com/device/K972807
Methodology: https://510kreport.com/methodology