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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over-The-Counter Hair Removal
510(k) Number K251914
Device Name IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)
Applicant
Miley Technology (Hebei) Co., Ltd.
Bldg. 3, High Tech Industrical Zone, S. Of Xinneng St.
Economic Development Zone, Guantao County
Handan,  CN 057750
Applicant Contact Caixia Sun
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Rm. 1509, Jingting Bldg., Dongzhou Community, Guangming St.,
Shenzhen,  CN 518107
Correspondent Contact Caixia Sun
Regulation Number878.4810
Classification Product Code
OHT  
Date Received06/23/2025
Decision Date 09/15/2025
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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