# K980418: Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and Toric Soft (Hydrophilic) Contact Lenses for Daily Wer

- Pathway: 510(k) (Traditional)
- Applicant: Benz Research and Development Corp.
- Decided: Feb 27, 1998 after 24 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K023989: Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut) (2003), 1 descendant of its own
- K133403: Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses, Firesoft-49G Daily Wear Contact Lens (2014), 0 descendants of its own
- K011577: Ocu-Flex 55 Spherical, Toric,Thin Zone Toric,Aspherical,Toric Aspherical and Thin Zone Toric Aspherical (Methafilcon a)S (2001), 0 descendants of its own

## Indications for use
The BENZ methafilcon A soft (hydrophilic) spherical and. toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens. The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity. The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction. The BENZ methafilcon A optical blanks are lathed into a soft (hydrophilic) spherical or toric hemispherical shell. The spherical lenses have a spherical base curve and the toric lenses have a non-spherical base curve. The lenses may be disinfected using chemical disinfection systems.

Source page: https://510kreport.com/device/K980418
Methodology: https://510kreport.com/methodology