Skip to content

Comfortkone Keratoconus Aspheric (Hybufocon a, Filofilcon a, Pemufocon a) Rigid Gas Permeable (Rgp) Daily Wear Contact

by Metro Optics, Inc.

510(k) K024164

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK024164 Date12 Feb 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HQD
Device Class
Class II
Regulation
21 CFR Part 886.5916
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Comfortkone Keratoconus Aspheric is a rigid gas permeable daily wear contact lens manufactured from hybufocon A, filofilcon A, or pemufocon A. It is designed for the management of keratoconus in patients with otherwise non-diseased eyes and may be prescribed for the correction of refractive ametropia, including myopia and hyperopia.

This device is intended for daily wear and is lathe-cut from lens blanks. It has received FDA 510(k) clearance under regulation number 886.5916. The lens is categorized as a class 2 medical device within the ophthalmic specialty.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical use for the Comfortkone Keratoconus Aspheric lens?

    This lens is specifically designed for the management of keratoconus in patients who have otherwise non-diseased eyes. Additionally, it may be prescribed to correct refractive ametropia, including conditions such as myopia and hyperopia.

  • What materials are used to manufacture these rigid gas permeable lenses?

    The Comfortkone Keratoconus Aspheric lenses are lathe-cut from lens blanks composed of hybufocon A, filofilcon A, or pemufocon A. These materials are selected to provide the necessary rigid gas permeable properties required for daily wear.

  • What is the regulatory status of this device?

    The Comfortkone Keratoconus Aspheric has received FDA 510(k) clearance under regulation number 886.5916. It is classified as a class 2 medical device within the ophthalmic specialty, indicating it has been found substantially equivalent to legally marketed predicate devices.