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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K254168
Device Name Actolind® (06.3637. Actolind® Gel Plus)
Applicant
ACTO GmbH
Büchnerstrasse 11 - 38118 Braunschweig
Schulstrasse 8 - 31613 Wietzen-Holte
Braunschweig,  DE 38118
Applicant Contact Ahmet Kilic
Correspondent
ACTO GmbH
Büchnerstrasse 11 - 38118 Braunschweig
Schulstrasse 8 - 31613 Wietzen-Holte
Braunschweig,  DE 38118
Correspondent Contact Ahmet Kilic
Classification Product Code
FRO  
Date Received12/23/2025
Decision Date 09/22/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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