# K021977: Hybrid FS & Hybrid FS Toric (Hycofocon a) RGP Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Contamac, Ltd.
- Decided: Sep 12, 2002 after 87 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K032256: Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a, Paflufocon B) Rigid Gas Permeable (RGP) Daily Wear Contact LE (2003), 0 descendants of its own

## Indications for use
The Contamac Hybrid FS (hybufocon A) RGP Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and low level corneal toricity up to 2.000) in aphakic or not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfection only. The Contamac Hybrid FS Toric (hybufocon A) RGP Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism where a spherical lens does not neutralize any residual over-refraction) in aphakic or not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfection only.

Source page: https://510kreport.com/device/K021977
Methodology: https://510kreport.com/methodology