# K981252: Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue Visibility Tinted, Lathe-Cut FR)

- Pathway: 510(k) (Traditional)
- Applicant: Alden Optical Labs., Inc.
- Decided: Jun 23, 1998 after 78 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 2 (0 Class I)
- 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.
6 later devices descend from it; 3 cite it directly.
0 of 8 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) Alden Classic: named in the summary without a submission number
- (no number) Satureyes: named in the summary without a submission number
- (no number) Satureyes Toric: named in the summary without a submission number

## Most influential descendants
- K983278: Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted an Non-Sighted Eyes) (1998), 3 descendants of its own
- K992950: Custom Prosthetic (Hefilcon a) Soft Lens (1999), 2 descendants 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
- K060821: Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact Lenses (2006), 0 descendants of its own
- K041700: Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily Wear (2004), 0 descendants of its own

## Recalls of this device
- Nov 3, 2017 · Class II · Z-0984-2018: Contact lenses lack sterility assurance.
- Nov 3, 2017 · Class II · Z-0987-2018: Contact lenses lack sterility assurance.

## Indications for use
The OXYLENS (hioxifilcon B) Spherical 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 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The OXYLENS (hioxifilcon B) Toric 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. The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.

Source page: https://510kreport.com/device/K981252
Methodology: https://510kreport.com/methodology