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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 K182407
Device Name Exceed Microneedling device
Mt. Derm GmbH
Berlin,  DE 14167
Applicant Contact Andreas Pachten
Ismart Marketing Svcs
129 Green Lanes, Wylde Green
Birmingham,  GB B735LT
Correspondent Contact Susan D'Arcy
Regulation Number878.4430
Classification Product Code
Date Received09/04/2018
Decision Date 07/19/2019
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