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Flexlens Multifocal Soft Contact Lens (Hioxifilcon A) and (Hioxifilcon B) for Daily Wear

by X-Cel Contacts 510(k)

Active United States

510(k) K070308

Overview

This device is a multifocal soft contact lens designed for daily wear, made from Hioxifilcon A and Hioxifilcon B materials. It is intended to correct vision in patients with presbyopia by providing multiple focal points within a single lens.

The lens is supplied as a reusable or single-use device depending on the specific product variant, though the data does not specify sterility, MRI safety, sizes, or storage conditions. It is authorized under FDA 510(k) clearance (K070308) and classified as a Class II medical device under regulation number 886.5925, with product code LPL and ophthalmic specialty designation.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070308 Date12 Mar 2007ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from X-Cel Contacts

Questions

  • What is the FLEXLENS multifocal soft contact lens used for?

    The FLEXLENS multifocal soft contact lens is designed to correct vision in patients with presbyopia by providing multiple focal points within a single lens, enabling clear near and distance vision during daily wear.

  • Is the FLEXLENS lens supplied as reusable or single-use?

    The FLEXLENS lens is supplied as either a reusable or single-use device depending on the specific product variant, though the data does not specify which variants correspond to which usage type.

  • What materials are used to make the FLEXLENS multifocal contact lens?

    The FLEXLENS multifocal soft contact lens is made from Hioxifilcon A and Hioxifilcon B materials, which are hydrogel polymers commonly used in soft contact lenses for comfort and oxygen permeability.