# K990895: Oxycon Lens

- Pathway: 510(k) (Traditional)
- Applicant: Concise Contact Lens Co.
- Decided: Apr 14, 1999 after 28 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- 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 K974636 (1998). 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)
- K974636: Flosi Rigid Gas Permeable Contact Lens, Futuristic Design Assoc. (1998) Summary page 1.

## Indications for use
Oxycon (wilofocon A) Rigid Gas Permeable, Spherical, Aspherical, Toric, and Bifocal Contact Lenses are indicated for daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K990895
Methodology: https://510kreport.com/methodology