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Airperm Siflufocon A Rigid Gas Permeable Multifocal Contact Lenses

by Airperm, Inc.

510(k) K962934

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 NumberK962934 Date27 Aug 1996ClearedStatusActive

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  • Withdrawn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)

Full name
Airperm(Siflufocon a) Rigid Gas Permeable Multifocal Contact Lenses for Daily Wear
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, 6 Oct 2026

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

The Airperm Siflufocon A Rigid Gas Permeable Multifocal Contact Lenses are daily wear lenses for the correction of refractive ametropia. They are a type of contact lens made of rigid gas permeable material. The lenses are aspheric, containing an aspherical curve on either the front or back surface. They are manufactured using the lathing method.

The Airperm Siflufocon A Rigid Gas Permeable Multifocal Contact Lenses are supplied for daily wear and may be disinfected using a chemical disinfection system. They are classified as a Class II device with product code HQD. The device has been cleared under FDA 510(k) number K962934.

Other devices from Airperm, Inc.

Questions

AI-generated answers, 6 Oct 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 Airperm Siflufocon A lens used for?

    The Airperm Siflufocon A Rigid Gas Permeable Multifocal Contact Lenses are designed for daily wear to correct refractive ametropia. They are aspheric lenses with an aspherical curve on either the front or back surface.

  • How are these lenses supplied and maintained?

    The lenses are supplied for daily wear and can be disinfected using a chemical disinfection system. They are manufactured using the lathing method by Airperm, Inc.

  • Are these lenses single-use or reusable?

    These lenses are intended for daily wear, meaning they are removed at night. While they are not strictly single-use, they require daily disinfection with a chemical system to maintain hygiene and safety.

  • What material are they made of?

    The lenses are made of rigid gas permeable material, specifically Siflufocon A, which allows oxygen to pass through the lens to the cornea, supporting eye health during wear.

  • What is the regulatory classification of this device?

    The Airperm Siflufocon A lenses are classified as a Class II medical device with product code HQD. They were cleared under FDA 510(k) number K962934 as substantially equivalent to an existing device.