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Contact Lens Case

by E-Link Plastic & Metal Industrial Co., Ltd

510(k) K171539

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 NumberK171539 Date14 Jul 2017ClearedStatusActive

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  • Withdrawn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
LRX
FDA applicant
E-Link Plastic & Metal Industrial Co.,Ltd
Device Class
Class II
Regulation
21 CFR Part 886.5928
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 Contact Lens Case is a device used for storing contact lenses. It is classified as a class 2 device and is described as substantially equivalent. The device is used in the ophthalmic field.

The Contact Lens Case is supplied as a single unit and is intended for use in storing contact lenses. It is regulated under the regulation number 886.5928 and has been cleared by the FDA under the traditional clearance type with the k number K171539. The device is manufactured by E-Link Plastic & Metal Industrial Co., Ltd.

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 Contact Lens Case used for?

    The Contact Lens Case is used for storing contact lenses, providing a safe and clean environment for the lenses when not in use.

  • Is the Contact Lens Case supplied as a single unit or in multiples?

    The Contact Lens Case is supplied as a single unit, intended for individual use in storing contact lenses.

  • What regulatory number governs the Contact Lens Case?

    The Contact Lens Case is regulated under the regulation number 886.5928, which outlines the requirements for such devices in the ophthalmic field.

  • What is the FDA clearance status of the Contact Lens Case?

    The Contact Lens Case has been cleared by the FDA under the traditional clearance type with the k number K171539, indicating its substantial equivalence to existing devices.