Cleared Traditional

LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)

K253712 · Shenzhen Rainbow Technology Co., Ltd. · General & Plastic Surgery

Jan 2026

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K253712 is an FDA 510(k) clearance for the LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073), a Light Based Over The Counter Wrinkle Reduction (Class II — Special Controls, product code OHS), submitted by Shenzhen Rainbow Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 23, 2026, 60 days after receiving the submission on November 24, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K253712 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2025
Decision Date	January 23, 2026
Days to Decision	60 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OHS — Light Based Over The Counter Wrinkle Reduction
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.