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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 K212318
Device Name IPL Hair Removal
Applicant
Dongguan Define Beauty Electronic Technology Co., Ltd.
#10 Xiangya Rd., Chicken Wing Ridge Village
Dongguan,  CN 523821
Applicant Contact Shaowu Wang
Correspondent
Cytech (Shenzhen) Enterprise Management Consulting Co., Ltd.
Rm. B204, Bldg. 12 Hourui 2nd Industrial Zone,
Bao'An District
Shezhen,  CN 518128
Correspondent Contact Helen Nan
Regulation Number878.4810
Classification Product Code
OHT  
Date Received07/26/2021
Decision Date 01/14/2022
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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