# K983496: Resolution 45 (Spherical) and Ultra Gel (Toric) (Hioxifilcon B) Soft Daily Wear Contact Lens, )Clear & Blue Visibility T

- Pathway: 510(k) (Traditional)
- Applicant: Opti-Centre Laboratories
- Decided: Mar 29, 1999 after 175 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: 1 generation back to K964528 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964528: (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint, Benz Research and Development Corp. (1997) Summary page 3.
- (no number) Horizon 55 Spherical: named in the summary without a submission number
- (no number) Westhin Toric: named in the summary without a submission number

## Indications for use
The Resolution 45 (Spherical) (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The Ultra Gel (Toric) (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters.

Source page: https://510kreport.com/device/K983496
Methodology: https://510kreport.com/methodology