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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)

Manufacturer

SZ KKS Silicone&Electronic Co., Ltd.

Date Cleared

2026-02-12

(59 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Age Range

All

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

LED Light Therapy Silicone Face Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

Device Description

Not Found

AI/ML Overview

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