510(k) K252784

eXaSkin Plus by Anatomical Geometry S.L. — Product Code MUJ

K252784 is an FDA 510(k) premarket notification submitted by Anatomical Geometry S.L. for the device "eXaSkin Plus". The FDA issued a decision of Substantially Equivalent on May 22, 2026. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2026
Date Received
September 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type