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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 K251707
Device Name IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
Applicant
Shenzhen Huachuangtong Industrial Co., Ltd.
Bldg. 1, 3rd Floor, Zhuolinxing Industrial Park, Liaokeng
3rd Industrial Zn, Baoyuan Community, Shiyan St., Bao'An Dis
Shenzhen,  CN 518108
Applicant Contact Qixin Huang
Correspondent
Shenzhen Huachuangtong Industrial Co., Ltd.
Bldg. 1, 3rd Floor, Zhuolinxing Industrial Park, Liaokeng
3rd Industrial Zn, Baoyuan Community, Shiyan St., Bao'An Dis
Shenzhen,  CN 518106
Correspondent Contact Jenny Wu
Regulation Number878.4810
Classification Product Code
OHT  
Date Received06/03/2025
Decision Date 08/01/2025
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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