# K964528: (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint

- Pathway: 510(k) (Traditional)
- Applicant: Benz Research and Development Corp.
- Decided: Mar 7, 1997 after 115 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.
51 later devices descend from it; 11 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BENZ-G 55 (5X) (hioxifilcon A): named in the summary without a submission number

## Most influential descendants
- K024045: Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut) (2003), 34 descendants of its own
- K073621: Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue Visibility Tint (2008), 33 descendants of its own
- K100221: INTELLIWAVE3 (2010), 32 descendants of its own
- K142641: Intelliwave4 (2015), 12 descendants of its own
- K152046: Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) (2015), 11 descendants of its own

## Indications for use
BENZ-G 3X Spherical (hioxifilcon B} soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or a blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic persons with with non-diseased eyes., The Spherical lenses are available from +20.00 to - 20.00 Diopters for versons who have up to 1.50 Diopters of astigmatism where the astagmatism does not interfere with visual acuity. BENZ-G 3X Toric (hioxifilcon B) soft (hydrcphilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic persons with 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.

Source page: https://510kreport.com/device/K964528
Methodology: https://510kreport.com/methodology