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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)

Manufacturer

Guangdong Ace-Tec Co., Ltd.

Date Cleared

2025-12-08

(81 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

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N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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