# K252784: eXaSkin Plus

- Pathway: 510(k) (Traditional)
- Applicant: Anatomical Geometry S.L.
- Decided: May 22, 2026 after 262 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K000137 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211511: decimal Bolus, .Decimal, LLC (2021) Summary page 5.

## Indications for use
eXaSkin is a medical device intended to be used as a bolus for the treatment of neoplastic skin lesions through radiotherapy. The product is designed to be applied to the irradiated area by qualified healthcare professionals to address anatomical irregularities and ensure precise delivery of the prescribed dose to the skin and underlying tissues during a radiation therapy treatment. eXaSkin was evaluated using 6 MV photons but has not been assessed for use with 10 MV photons, protons, or orthovoltage X-rays. eXaSkin Plus 150 and 225 is intended for general radiotherapy use. eXaSkin Plus 650 is intended for use on breast tissue.

Source page: https://510kreport.com/device/K252784
Methodology: https://510kreport.com/methodology