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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 K253881
Device Name Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
Applicant
Shenzhen Fansizhe Science And Technology Co., Ltd.
2nd, 3rd And 4th Floors, #11, Henggangxia Industrial Zone
Xiangshan Community, Xinqiao St., Bao’An District
Shenzhen,  CN 518125
Applicant Contact Endang Cheng
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center
# 3101-90, Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Youshan Gong
Regulation Number878.4810
Classification Product Code
OHT  
Date Received12/04/2025
Decision Date 12/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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