# K990264: Comfortkone, Keratoconus Aspheric, Rigid Gas Permeable (RGP), Daily Wear Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Metro Optics of Austin, Inc.
- Decided: Mar 31, 1999 after 63 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 K945955 (1995). 1 ancestor in all.
30 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945955: Rose K Lens, Rose K International, Ltd. (1995) Summary page 2.

## Most influential descendants
- K033594: Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses (2004), 28 descendants of its own
- K153066: BostonSight IC Corneal Lens, BostonSight IC Scleral Lens (2016), 20 descendants of its own
- K161461: BostonSight PD Prosthetic Device (2016), 19 descendants of its own
- K171404: BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) (2017), 14 descendants of its own
- K180616: OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens (2018), 9 descendants of its own

## Indications for use
The ComfortKone™ Keratoconus Aspheric (paflufocon C) 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/K990264
Methodology: https://510kreport.com/methodology