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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 K242619
Device Name GroWell BT Hair Growth System (GW10042)
Applicant
Apira Science Inc
409 Edmon Rd. NE Suite C
Albuquerque,  NM  87107
Applicant Contact Ray Pizinger
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center,
No. 3101-90, Qianhai Road
Shenzhen,  CN 518052
Correspondent Contact Tracy Che
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/03/2024
Decision Date 12/02/2024
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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