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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 K240264
Device Name Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)
Applicant
Shenzhen Mlay Intelligent Technology Co., , Ltd.
302,401, Bldg. 1, # 2, Xiashiwei Rd., Huaide 
Community, Fuyong St., Baoan District
Shenzhen,  CN 518000
Applicant Contact Liu Libin
Correspondent
Shenzhen Mlay Intelligent Technology Co., , Ltd.
302,401, Bldg. 1, # 2, Xiashiwei Rd., Huaide 
Community, Fuyong St., Baoan District
Shenzhen,  CN 518000
Correspondent Contact Liu Libin
Regulation Number878.4810
Classification Product Code
OHT  
Date Received01/31/2024
Decision Date 03/08/2024
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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