# K250692: GentleBeam (GB1000)

- Pathway: 510(k) (Traditional)
- Applicant: Voxel Ray Solutions, LLC
- Decided: Dec 3, 2025 after 271 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962613 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150037: Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities, Sensus Healthcare (2015) Summary page 5.

## Indications for use
The GentleBeam is a low energy x-ray system, with imaging capability, intended for superficial radiotherapy treatments of primary malignant epithelial neoplasms of the skin and keloids. Applications include: (a) basal cell carcinoma; (b) squamous cell carcinoma; (c) Metatypic carcinoma; (d) cutaneous appendage carcinoma (e) Kaposi’s Sarcoma; and (f) the treatment of keloids. Keloids are benign fibrous growths that arise from proliferation of dermal tissue typically arising from injuries to skin tissue. The imaging capability, employed in a non-diagnostic mode, is used to assist the physician in the selection of the correct treatment area. The imaging component is a laser induced ultrasound scanning system used to visualize the layers of skin, including blood vessels, and to make approximate measurements of dimensions in layers of skin and blood vessels, by detecting laser pulse generated ultrasound waves.

Source page: https://510kreport.com/device/K250692
Methodology: https://510kreport.com/methodology