# K172080: Photoelectric Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Xstrahl, Ltd.
- Decided: Sep 29, 2017 after 81 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962613 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123985: Sensus Healthcare Superficial Radiotherapy System SRT-100, Sensus Healthcare (2013) Summary page 4.

## Most influential descendants
- K230611: X80 / RADiant / PhotoElectric Therapy System  (RADiant Aura) (2023), 0 descendants of its own

## Recalls of this device
- Apr 27, 2022 · Class II · Z-1404-2022: There is a potential compatibility issue with the systems and replacement treatment applicators.
- Apr 26, 2021 · Class II · Z-0174-2022: If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatmen

## Indications for use
The Xstrahl Photoelectric Therapy System is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids. Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Metatypic Carcinoma, Cutaneous Appendage Carcinoma, Karposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Cutaneous Lymphomas (B and T cell) and Keloids.

Source page: https://510kreport.com/device/K172080
Methodology: https://510kreport.com/methodology