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510(k) Data Aggregation

K Number

Device Name

LED Beauty Mask (RLBXX)

Manufacturer

ATOP Lighting Co., Ltd.

Date Cleared

2025-11-13

(112 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The LED Beauty Mask is an over-the-counter device that is intended for use in the treatment of full-face wrinkles.

Device Description

This product is based on low-energy red light therapy (LED Phototherapy), which achieves through precise wavelength control:

Wavelength selection: Using 630 red light and 830nm near-infrared light to treat wrinkle for 25-50 years women

The main body of the mask is made of medical-grade silicone, with a total weight of ≤300g, and an elastic headband, which can be worn for a long time without pressure.

AI/ML Overview

N/A

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