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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K253004
Device Name LUNA 3D
Applicant
Lap GmbH Laser Applikationen
Zeppelinstraße 23
Lüneburg,  DE 21337
Applicant Contact Sebastian Boldhaus
Correspondent
Lap GmbH Laser Applikationen
Zeppelinstraße 23
Lüneburg,  DE 21337
Correspondent Contact Sebastian Boldhaus
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/19/2025
Decision Date 06/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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