# K974636: Flosi Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Futuristic Design Assoc.
- Decided: Mar 30, 1998 after 108 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K990895: Oxycon Lens (1999), 0 descendants of its own

## Indications for use
FLOSI (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/K974636
Methodology: https://510kreport.com/methodology