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LED Light Therapy Mask (RT01)

by Ningbo Dechang Electrical Machinery Made Co., Ltd

510(k) K242068

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 NumberK242068 Date4 Apr 2025ClearedStatusActive

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  • Withdrawn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
Ningbo Dechang Electrical Machinery Made 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, 28 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 LED Light Therapy Mask (RT01) is an over-the-counter powered light-based laser device for acne, as defined in its device name and openFDA data. It is a wearable mask that delivers light therapy to the skin for the treatment of acne lesions.

It is supplied as a non-sterile, reusable device intended for use in home or clinical settings. The device received FDA 510(k) clearance (K242068) on April 4, 2025, and is classified as a Class II medical device under regulation number 878.4810. No information on MRI safety, specific sizes, or storage conditions is provided in the data.

Other devices from Ningbo Dechang Electrical Machinery Made Co., Ltd

Questions

AI-generated answers, 28 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 LED Light Therapy Mask (RT01) used for?

    The LED Light Therapy Mask (RT01) is used for the treatment of acne lesions by delivering light therapy to the skin, as specified in its device name and regulatory documentation.

  • Is the LED Light Therapy Mask (RT01) sterile or non-sterile, and is it intended for single use or reuse?

    The device is supplied as a non-sterile, reusable device, meaning it is not provided in a sterile condition and is designed for multiple uses over time in home or clinical environments.

  • What regulatory pathway was used for the LED Light Therapy Mask (RT01), and what is its classification?

    The LED Light Therapy Mask (RT01) received FDA 510(k) clearance under K242068 on April 4, 2025, and is classified as a Class II medical device under regulation number 878.4810.