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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 K220543
Device Name Auxo A300, A150 and APod
Applicant
Auxo Hair, LLC
16300 SW 101 Ave
Miami,  FL  33157
Applicant Contact Patricia Schnoor
Correspondent
Auxo Hair, LLC
16300 SW 101 Ave
Miami,  FL  33157
Correspondent Contact Patricia Schnoor
Regulation Number890.5500
Classification Product Code
OAP  
Date Received02/25/2022
Decision Date 04/20/2022
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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