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Tinted Ocu-Flex 53 (Occufilcon B) Soft Hydrophilic Contact Lens

by Ocu-Ease Optical Products, Inc.

510(k) K960291

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 NumberK960291 Date25 Mar 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  • Withdrawn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)

510(k) Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

This device is a tinted soft hydrophilic contact lens made from occufilcon B material, designed for daily wear vision correction. It is available in spherical, toric, and aspherical configurations and incorporates Reactive Blue 21 dye for handling visibility and aesthetic preference.

The lens is supplied as a single-use device for daily wear and is regulated under FDA 510(k) clearance K960291 with product code LPL and regulation number 886.5925. It is manufactured by Ocu-Ease Optical Products, Inc. and classified as a Class II ophthalmic device.

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Questions

AI-generated answers, 25 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 TINTED OCU-FLEX 53 contact lens used for?

    The TINTED OCU-FLEX 53 is designed for daily wear vision correction. It is a soft hydrophilic contact lens made from occufilcon B material and incorporates Reactive Blue 21 dye to enhance handling visibility and provide aesthetic preference, helping users see and manage the lens more easily during insertion and removal.

  • How is the TINTED OCU-FLEX 53 supplied and is it reusable?

    The lens is supplied as a single-use device intended for daily wear. It is not designed for reuse and should be discarded after each day of use to maintain safety and performance, as specified in its regulatory documentation.

  • What configurations are available for the TINTED OCU-FLEX 53 lens?

    The TINTED OCU-FLEX 53 is available in spherical, toric, and aspherical configurations to accommodate different vision correction needs, including myopia, hyperopia, astigmatism, and higher-order aberrations, while maintaining the tinted handling feature across all designs.