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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 K212314
Device Name IPL Hair Removal Device
Applicant
Zhongshan Bisen Plastic Electronic Products Co., Ltd.
Second Floor, A Bldg., #32 Jianye Rd.,
Torch Development Zone
Zhongshan,  CN 528437
Applicant Contact Rao Guanhua
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, Block A, Zhongguan Times Square, Liuxian
Ave. Xili Town
Shenzhen,  CN 518000
Correspondent Contact Mark Leung
Regulation Number878.4810
Classification Product Code
OHT  
Date Received07/23/2021
Decision Date 10/21/2021
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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