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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 K213025
Device Name Laser hair growth helmet
Applicant
Kam Yuen Plastic Products Ltd.
No. 2, Hengfeng 2nd Road, Pujin Industrial, Konghou Town
Zhongshan,  CN 528400
Applicant Contact Anna Dan
Correspondent
Guangdong Jianda Medical Technology Co Ltd
906 Room, Longxiang Garden, Tianhe District
Guangzhou,  CN
Correspondent Contact Jett Lee
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/21/2021
Decision Date 05/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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