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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 K254047
Device Name Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)
Applicant
Shenzhen Chuangtong Yigou Technology Co., Ltd.
Rm. 2218, Rongchuang Zhihui Bldg. A
Shangfen Community, Minzhi St., Longhua District
Shenzhen,  CN
Applicant Contact Kingway Hong
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Candice Qiu
Regulation Number878.4810
Classification Product Code
OHT  
Date Received12/17/2025
Decision Date 03/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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