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DemarkQ WOW, DemarkQ POP

by Shenzhen Kaiyan Medical CO, Ltd.

510(k) K203214

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 NumberK203214 Date22 Jul 2021ClearedStatusActive

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  • Withdrawn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
OLP
FDA applicant
Shenzhen Kaiyan Medical CO , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
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 DemarkQ WOW, DemarkQ POP is an over‑the‑counter powered light‑based laser indicated for the treatment of mild to moderate acne. It is classified as a Class II device and is listed under product code OLP in the FDA device classification system.

The device is manufactured by Shenzhen Kaiyan Medical Co., Ltd. and received FDA 510(k) clearance (K203214) on July 22, 2021 under regulation 21 CFR 878.4810. It is intended for use in general and plastic surgery settings as well as dermatology, and is supplied as a cleared medical device in accordance with the listed specifications.

Other devices from Shenzhen Kaiyan Medical 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 DemarkQ WOW, DemarkQ POP used for?

    It is an over-the-counter powered light-based laser indicated for the treatment of mild to moderate acne. It is intended for use in general and plastic surgery settings as well as dermatology.

  • How is the device supplied?

    The device is supplied as a cleared medical device in accordance with the listed specifications. It is manufactured by Shenzhen Kaiyan Medical Co., Ltd. and is available for purchase as an over-the-counter product.

  • Is the DemarkQ WOW, DemarkQ POP a single-use or reusable device?

    The device data does not specify whether it is single-use or reusable. This information would typically be found in the product labeling or instructions for use, which are not included in the provided data.

  • What sizes and models are available?

    The device is listed under the names DemarkQ WOW and DemarkQ POP. The data does not provide specific information about different sizes or models available for this device.

  • How should the device be stored?

    The device data does not include specific storage instructions. Storage requirements would typically be detailed in the product's instructions for use or labeling, which are not provided in the current dataset.