# K024164: Comfortkone Keratoconus Aspheric (Hybufocon a, Filofilcon a, Pemufocon a) Rigid Gas Permeable (RGP) Daily Wear Contact

- Pathway: 510(k) (Traditional)
- Applicant: Metro Optics, Inc.
- Decided: Feb 12, 2003 after 57 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: 2 generations back to K945955 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990264: Comfortkone, Keratoconus Aspheric, Rigid Gas Permeable (RGP), Daily Wear Contact Lens, Metro Optics of Austin, Inc. (1999) Summary page 2.

## Indications for use
The ComfortKoneTM Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank) is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical disinfection system.

Source page: https://510kreport.com/device/K024164
Methodology: https://510kreport.com/methodology