# K974599: Ultravue/P, Ultralvue/C (Hioxifilcon B)) Soft (Multifocal) Daily Wear Contact Lens (Clear & Yinted, Lathe-Cut From Lens)

- Pathway: 510(k) (Traditional)
- Applicant: Opti-Centre Laboratories
- Decided: Mar 2, 1998 after 83 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) Bi-Soft: named in the summary without a submission number
- (no number) LifeStyle 4-Vue: named in the summary without a submission number
- (no number) LifeStyle Xtra: named in the summary without a submission number
- (no number) Horizon 55 Bicon: named in the summary without a submission number
- (no number) Ocu-Flex-53: named in the summary without a submission number
- (no number) SimulVue: named in the summary without a submission number

## Indications for use
The UltraVue/P, UlraVue/C (hioxifilcon B) Soft (Multifocal) Contact Lenses for daily wear arc indicated for the correction of visual acuity in aphakic and not aphakic persons with non-discased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

Source page: https://510kreport.com/device/K974599
Methodology: https://510kreport.com/methodology