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Ultravue/P 2000T, Ultravue/C 2000T (Hioxifilcon B) Soft (Multifocal Toric) Daily Wear Contact Lens (Clear & Blue Visibil

by Opti-Centre Laboratories

510(k) K010256

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 NumberK010256 Date26 Mar 2001ClearedStatusActive

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  • Withdrawn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, 23 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 soft multifocal toric daily wear contact lens made from Hioxifilcon B material. It is designed for vision correction in patients with presbyopia and astigmatism, offering both clear and blue visibility tints for handling ease.

The lens is supplied as a single-use daily wear product and is intended for use in ophthalmic settings. It received FDA 510(k) clearance under K010256 and is classified as a Class II medical device under regulation number 886.5925. Storage and handling should follow standard contact lens practices as implied by its daily wear designation.

Other devices from Opti-Centre Laboratories

Questions

AI-generated answers, 23 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 ULTRAVUE/P 2000T and ULTRAVUE/C 2000T contact lens used for?

    This device is designed for vision correction in patients with presbyopia and astigmatism, combining multifocal and toric optics to address both near and distance vision needs while correcting corneal irregularities.

  • How is the ULTRAVUE/P 2000T and ULTRAVUE/C 2000T contact lens supplied and intended for use?

    The lens is supplied as a single-use daily wear product, meaning each lens is discarded after one day of use, and is intended for use in ophthalmic settings under professional guidance.

  • What material is the ULTRAVUE/P 2000T and ULTRAVUE/C 2000T contact lens made from, and what visibility tints are available?

    The lens is made from Hioxifilcon B material and is offered in both clear and blue visibility tints to enhance handling ease during insertion and removal.