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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 K253666
Device Name IPL Hair Removal Device (Models: T31A, T32A)
Applicant
Shenzhen Mlay Intelligent Technology Co., Ltd.
201, 301, Bldg. 28, Cuigang Industrial Zone 2
Huaide Community, Fuyong St., Baoan District
Shenzhen,  CN 518103
Applicant Contact Libin Liu
Correspondent
Shenzhen Mlay Intelligent Technology Co., Ltd.
201, 301, Bldg. 28, Cuigang Industrial Zone 2
Huaide Community, Fuyong St., Baoan District
Shenzhen,  CN 518103
Correspondent Contact Libin Liu
Regulation Number878.4810
Classification Product Code
OHT  
Date Received11/21/2025
Decision Date 02/23/2026
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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