510(k) · Cleared
ClearedGentleBeam (GB1000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voxel Ray Solutions, LLC · JAD System, Therapeutic, X-Ray
Cleared on Dec 3, 2025 as substantially equivalent to K150037 (Sensus Healthcare, 2015) after a 271-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Dec 3, 2025
- Review
- 271 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962613 (1996). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK962613 Darpac 2000 Superficial X-Ray Therapy SystemGulmay Medical, Ltd. · 1996 · Recalled
- 4 generations backK063456 SRT100 Superficial Radiation Therapy SystemTopex, Inc. · 2007
- 3 generations backK123985 Sensus Healthcare Superficial Radiotherapy System SRT-100Sensus Healthcare · 2013
- 2 generations backK131582 Sensus Helthcare Image-Duided Superficial Radiotherapy SystemSensus Healthcare · 2013
- 1 generation backK150037 Sensus Healthcare Superficial X-ray Radiation Therapy System with…Sensus Healthcare · 2015 · Recalled
- This deviceK250692 GentleBeam (GB1000)Voxel Ray Solutions, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962613 | Darpac 2000 Superficial X-Ray Therapy System | Gulmay Medical, Ltd. | 1996 | 2 |
| −4 | K063456 | SRT100 Superficial Radiation Therapy System | Topex, Inc. | 2007 | — |
| −3 | K123985 | Sensus Healthcare Superficial Radiotherapy System SRT-100 | Sensus Healthcare | 2013 | — |
| −2 | K131582 | Sensus Helthcare Image-Duided Superficial Radiotherapy System | Sensus Healthcare | 2013 | — |
| −1 | K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic… | Sensus Healthcare | 2015 | 1 |
| 0 (this device) | K250692 | GentleBeam (GB1000) | Voxel Ray Solutions, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAD device
- #1 K241174 INTRABEAM (700); And accessories (INTRABEAM…score 11.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging…Summary page 5…(892.5900) Classification: Class II Product Code: JAD Regulation Number: 892.5900 Predicate Device: K150037 SRT-100 Vision 510(k) Summary (GentleBeam) Page 1 of 14 Device… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K150037.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JAD
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAD
114in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAD
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAD
1in 2025
MAUDE reports naming product code JAD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 106 | 2 | 5 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 3 |
| 2012 | 2 | — | 3 | 4 |
| 2013 | 5 | 114 | 0 | 12 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 1 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 0 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (134 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250692: GentleBeam (GB1000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250692
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026