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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, comb, hair
510(k) Number K191754
Device Name Hair Growth System
Applicant
Kunshan Bella Optical technology Co., Ltd.
Plant 2, Kunshan Development Zone,
No. 218 Cheng Hu Road
Kunshan,  CN 215300
Applicant Contact Wu Xuefeng
Correspondent
Kunshan Bella Optical technology Co., Ltd.
Plant 2, Kunshan Development Zone,
No. 218 Cheng Hu Road
Kunshan,  CN 215300
Correspondent Contact Wu Xuefeng
Regulation Number890.5500
Classification Product Code
OAP  
Date Received07/01/2019
Decision Date 11/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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