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Toricolors Hioxifilcon D Soft Contact Lenses

by Polydev, Ltd.

510(k) K161931

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 NumberK161931 Date12 Oct 2016ClearedStatusActive

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  • Withdrawn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
FDA applicant
Polydev , Ltd.
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.

Toricolors (hioxifilcon D) soft contact lenses are daily wear devices designed for vision correction and cosmetic eye color enhancement. They are indicated for the correction of myopia, hyperopia, and aphakia while simultaneously acting to alter or enhance the apparent color of the eye.

These lenses are supplied as monthly disposable toric lenses and are regulated under FDA 510(k) clearance. They are manufactured using a hioxifilcon D hydrogel copolymer material.

Other devices from Polydev, Ltd.