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Cvue Advanced Hydra Vue

by Unilens Corp., USA

510(k) K121652

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 NumberK121652 Date5 Oct 2012ClearedStatusActive

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  • Withdrawn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.

The CVUE ADVANCED HYDRA VUE is a soft contact lens designed for daily wear. It is classified as a Class II medical device under the ophthalmic specialty and is substantially equivalent to a predicate device as determined by FDA 510(k) clearance.

This device is supplied as a monthly custom silicone hydrogel toric multifocal contact lens. It is intended for use in the ophthalmic setting and is authorized under FDA 510(k) clearance K121652 with product code LPL and regulation number 886.5925.

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