Intense Pulsed Light Therapy Device (MMABM-1)— 510(k) K251545

Name: FDA 510(k) clearance K251545
Creator: U.S. Food and Drug Administration
Published: 2025-09-04

Substantially Equivalent

Micowey Medical Equipment (Guangxi) Co., Ltd.

FDA 510(k) clearance K251545 for Intense Pulsed Light Therapy Device (MMABM-1), Substantially Equivalent on 2025-09-04. Applicant: Micowey Medical Equipment (Guangxi) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Micowey Medical Equipment (Guangxi) Co., Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-05-20
Decision date: 2025-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuzhou, CN

Download summary PDF View on FDA.gov ↗

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