# K961103: Benz 38 Clear & with Blue Visibility Tint

- Pathway: 510(k) (Traditional)
- Applicant: Benz Research and Development Corp.
- Decided: Aug 23, 1996 after 156 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.
9 later devices descend from it; 3 cite it directly.
0 of 10 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 no predicate by number.

## Most influential descendants
- K980554: Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted (Transparent/Enhancing) (1998), 4 descendants of its own
- K983278: Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted an Non-Sighted Eyes) (1998), 3 descendants of its own
- K023987: Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut) (2003), 2 descendants of its own
- K992950: Custom Prosthetic (Hefilcon a) Soft Lens (1999), 2 descendants of its own
- K132714: Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and Cosmetic Tinted) (2014), 1 descendant of its own

## Indications for use
BENZ 38 (polvmacon) Spherical soft (hvdrophilic) contact lenses in clear or with blue visibility tint form are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with with non-diseased eves. The spherical lenses are being applied for from +12.00 to -20.00 Diopters and masking up to 1.50° Diopters of astigmatism where it does not interfere with visual acuity. BENZ 38 (poiymacon) Toric soft (hydrophilic) contact lenses in clear or with blue visibility tint form are also indicated for daily wear. The lenses are indicated for the correction of visual acuity in ncn-aphakic patients with with non-diseased eves. The spherical lenses are being applied for from +12.00 to -20.00 Diopters up to 4.50 Diopters of astigmatism where it does not interfere with visual acuity.

Source page: https://510kreport.com/device/K961103
Methodology: https://510kreport.com/methodology