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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 K213027
Device Name Laser Hair Growth Comb
Kam Yuen Plastic Products Ltd
No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town
ZhongShan,  CN 528400
Applicant Contact Anna Dan
Guangdong Jianda Medical Technology Co., Ltd.
906 Room, Longxiang Garden, Tianhe district
Guangzhou,  CN 510000
Correspondent Contact Jett Lee
Regulation Number890.5500
Classification Product Code
Date Received09/21/2021
Decision Date 05/26/2022
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