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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 K241790
Device Name XCELLARISPRO TWIST microneedling device
Applicant
Dermaroller GmbH
Wilhelm-Mast-Strasse 8
Wolfenbuettel,  DE 38304
Applicant Contact Anna Lena Kaufholz
Correspondent
Buchanan
1700 K St., NW, Suite 300
Washington,  DC  20006
Correspondent Contact Barbara A. Binzak Blumenfeld
Regulation Number878.4430
Classification Product Code
QAI  
Date Received06/21/2024
Decision Date 03/06/2025
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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