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Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)

by Visionary Optics, LLC

510(k) K233325

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233325 Date21 Feb 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 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  • Withdrawn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, 24 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 Visionary Optics Scleral Contact Lens is a large diameter rigid gas permeable contact lens designed to vault over the cornea and rest on the scleral conjunctiva. It is lathe-cut from fluorosilicone acrylate materials to manage irregular corneal shapes and ocular surface diseases by providing an expanded tear reservoir.

This device is prescribed by eye care practitioners for daily wear. It has received FDA 510(k) clearance under K233325.

Other devices from Visionary Optics, LLC

Questions

AI-generated answers, 24 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 purpose of the Visionary Optics Scleral Contact Lens?

    This lens is designed to vault over the cornea and rest on the scleral conjunctiva. It is used to manage irregular corneal shapes and ocular surface diseases by providing an expanded tear reservoir.

  • What materials are used to manufacture these lenses?

    The lenses are lathe-cut from fluorosilicone acrylate materials, specifically roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, or fluoroxyfocon A.

  • How is this device prescribed and worn?

    This device must be prescribed by an eye care practitioner and is intended for daily wear.

  • Has this device received regulatory clearance?

    Yes, the Visionary Optics Scleral Contact Lens has received FDA 510(k) clearance under submission number K233325.