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Ultravue/P, Ultralvue/C (Hioxifilcon B) Soft (Multifocal) Daily Wear Contact Lens (Clear & Yinted, Lathe-cut from Lens)

by Opti-Centre Laboratories

510(k) K974599

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 NumberK974599 Date2 Mar 1998ClearedStatusActive

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  • Withdrawn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, 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.

This device is a soft multifocal daily wear contact lens made from Hioxifilcon B material. It is lathe-cut from lens blanks and available in clear and yinted (blue visibility tint) versions. The lens is designed for daily wear and provides multifocal vision correction.

The device is supplied as a reusable contact lens intended for daily wear. It received FDA 510(k) clearance (K974599) as substantially equivalent to predicate devices. The lens is regulated under regulation number 886.5925 and classified as a Class II medical device.

Other devices from Opti-Centre Laboratories

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 ULTRAVUE/P, ULTRALVUE/C contact lens used for?

    The ULTRAVUE/P, ULTRALVUE/C is a soft multifocal daily wear contact lens designed to provide vision correction for presbyopia and other refractive errors, offering both distance and near vision correction in a single lens for daily wear use.

  • How is the ULTRAVUE/P, ULTRALVUE/C contact lens supplied and what materials is it made from?

    The lens is lathe-cut from lens blanks made of Hioxifilcon B material and is supplied as a reusable contact lens intended for daily wear, available in clear and yinted (blue visibility tint) versions to aid in handling and visibility during insertion and removal.

  • Is the ULTRAVUE/P, ULTRALVUE/C contact lens reusable or single-use, and what is its wear schedule?

    The device is supplied as a reusable contact lens intended for daily wear, meaning it is designed to be worn during waking hours and removed each night for cleaning and storage, with replacement following the prescribed schedule by an eye care professional.