# K992589: Resolution 5X (Spherical) and Ultra Gel 5X (Toric)(Hioxifilcon a) Soft Daily Wear Contact Lens, (Clear & Blue Visibility

- Pathway: 510(k) (Traditional)
- Applicant: Opti-Centre Laboratories
- Decided: Aug 26, 1999 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
Longest line of descent: 1 generation back to K952620 (1995). 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)
- K952620: Optical Blanks: BENZ55G Clear and Visibility Tinted, Benz Research and Development Corp. (1995) Summary page 3.
- (no number) Resolution 45 (Spherical) and Ultra Gel (Toric): named in the summary without a submission number

## Indications for use
The Resolution 5X (Spherical) (hioxifilcon A) 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 5X (Toric) (hioxifilcon A) 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/K992589
Methodology: https://510kreport.com/methodology