Cleared Traditional

LED Light Therapy Mask (RT01)

K242068 · Ningbo Dechang Electrical Machinery Made Co.,Ltd · General & Plastic Surgery

Apr 2025

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K242068 is an FDA 510(k) clearance for the LED Light Therapy Mask (RT01), a Over-the-counter Powered Light Based Laser For Acne (Class II — Special Controls, product code OLP), submitted by Ningbo Dechang Electrical Machinery Made Co.,Ltd (Yuyao, CN). The FDA issued a Cleared decision on April 4, 2025, 263 days after receiving the submission on July 15, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K242068 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2024
Decision Date	April 04, 2025
Days to Decision	263 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OLP — Over-the-counter Powered Light Based Laser For Acne
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulgaris.