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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,
# 218 Cheng Hu Rd.
Kunshan,  CN 215300
Applicant Contact Wu Xuefeng
Correspondent
Kunshan Bella Optical Technology Co., Ltd.
Plant 2, Kunshan Development Zone,
# 218 Cheng Hu Rd.
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
Predetermined Change
Control Plan Authorized		 No
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