Skip to content

Oren LED Perioral Light Therapy System

by Shenzhen Kaiyan Medical CO, Ltd.

510(k) K213024

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 NumberK213024 Date22 Dec 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  • Withdrawn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
OHS
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, 25 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 Oren LED Perioral Light Therapy System is a Class II medical device designed for over-the-counter use to reduce the appearance of fine lines and wrinkles in the perioral region. It employs light therapy technology with multiple LED wavelengths to target skin concerns in this area.

The device is portable and battery-operated, intended for single-use applications. It is cleared under FDA 510(k) K213024 and is not indicated for clinical use. Proper storage and handling are required to maintain device integrity.

Other devices from Shenzhen Kaiyan Medical CO, Ltd.

Questions

AI-generated answers, 25 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 Oren LED Perioral Light Therapy System used for?

    The Oren LED Perioral Light Therapy System is designed for over-the-counter use to reduce the appearance of fine lines and wrinkles in the perioral region. It employs light therapy technology with multiple LED wavelengths to target skin concerns in this specific area.

  • Is the Oren LED Perioral Light Therapy System reusable or single-use?

    The device is intended for single-use applications. It is portable and battery-operated, designed for one-time use to maintain device integrity and ensure safety for the user.

  • What regulatory clearance does the Oren LED Perioral Light Therapy System have?

    The device is cleared under FDA 510(k) K213024 as a Class II medical device. It is not indicated for clinical use and is intended for over-the-counter applications only.

  • How should the Oren LED Perioral Light Therapy System be stored?

    Proper storage and handling are required to maintain device integrity. While specific storage conditions aren't detailed in the provided information, it should be stored in a cool, dry place away from direct sunlight to preserve its functionality and extend its shelf life.