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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K251545
Device Name Intense Pulsed Light Therapy Device (MMABM-1)
Applicant
Micowey Medical Equipment (Guangxi) Co., Ltd.
Rm. 203, Bldg. B1, Xinghua Community,
High-Tech Industrial Development Zone, Wanxiu District
Wuzhou,  CN
Applicant Contact Angelina Lau
Correspondent
Sgs-Cstc Standards Technical Services Co., Ltd.
9198 Kezhu Rd.
Scientech Park Guangzhou Economic & Technology Development D
Guangzhou,  CN 510000
Correspondent Contact Iris Fung
Regulation Number878.4810
Classification Product Code
ONF  
Date Received05/20/2025
Decision Date 09/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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