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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Microneedle Device
510(k) Number K243472
Device Name 1NEED Pro
Applicant
Campomats S.R.L.
Via Monte Rosa 11
Riccione,  IT 47838
Applicant Contact Mats Erik Andreasson
Correspondent
Whitelab S.R.L.
Via Del Consorzio, 41
Falconara Marittima,  IT 60015
Correspondent Contact Chiara Violini
Regulation Number878.4430
Classification Product Code
QAI  
Date Received11/08/2024
Decision Date 03/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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