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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 K222598
Device Name IPL Hair Removal Device
Applicant
Shenzhen Noble Smart Manufacturing Tech Co., Ltd.
3f, Bldg. A, Zhengchangda Technology Park,
Jian'An, Fuhai Town, Bao'An District
Shenzhen,  CN 518103
Applicant Contact Guo Yi
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Rm. 1407, Jingting Bldg., Dongzhou Community, Guangming
St., Guangming District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
ONF  
Date Received08/29/2022
Decision Date 11/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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