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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 K221635
Device Name IPL sapphire ice cooling hair remove device
Applicant
Shenzhen Desida Technology Co., Ltd.
5th Floor, Bldg. A, Sanmin Industrial Zone,
Shilongzai, Shuitian Community, Shiyan St., Baoa
Shenzhen,  CN 518109
Applicant Contact Shuangcheng Yuan
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number878.4810
Classification Product Code
OHT  
Date Received06/06/2022
Decision Date 08/31/2022
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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