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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 K260899
Device Name Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)
Applicant
Zdeer Technology (Henan) Co., Ltd.
East Of Wei Wu Rd. And S. Of Qin Gong E. Rd.,
Toubao Village Committee, Laotown Town
Changge, Xuchang City,  CN 461500
Applicant Contact Wenlin Xiang
Correspondent
Zdeer Technology (Henan) Co., Ltd.
East Of Wei Wu Rd. And S. Of Qin Gong E. Rd.,
Toubao Village Committee, Laotown Town
Changge, Xuchang City,  CN 461500
Correspondent Contact Wenlin Xiang
Regulation Number890.5500
Classification Product Code
OAP  
Date Received03/18/2026
Decision Date 06/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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