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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K251076
Device Name Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
Applicant
Shenzhen Lifotronic Technology Co., Ltd.
Lifotronic Tower, # 8, Qiuzhi E. Rd.
Guancheng Community, Guanhu St., Longhua
Shenzhen,  CN 518110
Applicant Contact Lei Xiang
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui, #5
Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/08/2025
Decision Date 07/30/2025
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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