# K983278: Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted an Non-Sighted Eyes)

- Pathway: 510(k) (Traditional)
- Applicant: Alden Optical Labs., Inc.
- Decided: Nov 25, 1998 after 69 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: 2 generations back to K961103 (1996). 4 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K980554: Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted (Transparent/Enhancing), Alden Optical Labs., Inc. (1998) Summary page 4.
- K981252: Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue Visibility Tinted, Lathe-Cut FR), Alden Optical Labs., Inc. (1998) Summary page 4.
- 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 4.

## Most influential descendants
- K992950: Custom Prosthetic (Hefilcon a) Soft Lens (1999), 2 descendants of its own
- K041700: Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily Wear (2004), 0 descendants of its own
- K020690: Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact Lens (2002), 0 descendants of its own

## Indications for use
The OXYLENS PROSTHETIC (hioxifilcon B), Tinted Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with either a chemical or a heat disinfection system. The OXYLENS TINTED (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 lens may be disinfected with either a chemical or a heat disinfection system. The OXYLENS TINTED (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 lens may be disinfected with either a chemical or a heat disinfection system. The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.

Source page: https://510kreport.com/device/K983278
Methodology: https://510kreport.com/methodology