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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 K182501
Device Name Hair Laser Headband
Applicant
Pulsaderm, LLC
12801 Commonwealth Dr. Units 2-6
Fort Myers,  FL  33913
Applicant Contact Gloria Avendano
Correspondent
Pulsaderm, LLC
12801 Commonwealth Dr. Units 2-6
Fort Myers,  FL  33913
Correspondent Contact Gloria Avendano
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/12/2018
Decision Date 10/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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