Sequence Group led the regulatory strategy and 510(k) submission for the GentleBeam™ (GB1000) an innovative image-guided superficial radiation therapy device developed by Voxel Ray Solutions, LLC and commercialized by SkinCure Oncology for the treatment of nonmelanoma skin cancers.
FDA 510(k) Clearance
The GentleBeam (GB1000) is an image-guided superficial radiation therapy system. It uses laser-induced Photosonic™ technology to generate acoustic pressure waves that help physicians and radiation therapists visualize skin layers and blood vessels for precision treatment planning, daily dose delivery, and confirmation of tumor eradication in the treatment of nonmelanoma skin cancer (NMSC).
View FDA 510(k) Decision Letter (K250692) ↗The Challenge
The GentleBeam introduced a novel Photosonic™ imaging modality using laser-induced acoustic pressure waves to visualize skin layers and blood vessels combined with superficial radiation therapy delivery. Demonstrating substantial equivalence to predicate SRT devices while incorporating this new imaging technology required a carefully structured 510(k) with robust performance data and software documentation for the imaging component.
Our Solution
Sequence Group developed the complete 510(k) regulatory strategy and submission package, including predicate device analysis referencing the established SRT-100 product family (JAD classification, 21 CFR 892.5900). The submission included IEC 62304-compliant software documentation for the Photosonic imaging software, IEC 60601 electrical safety testing coordination, ISO 14971 risk management documentation, and performance testing demonstrating equivalence to cleared SRT predicates.
The Outcome
The GentleBeam (GB1000) received FDA 510(k) clearance (K250692) on December 3, 2025 just 9 months after submission in March 2025. SkinCure Oncology announced commercial availability in March 2026, expanding their GentleCure™ platform with the first imaging-integrated SRT device cleared for NMSC treatment. The device is now available through SkinCure Oncology's network of approximately 500 dermatology practices nationwide.
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Client
Voxel Ray Solutions, LLC / SkinCure Oncology
Services Provided
- 510(k) Regulatory Strategy
- Software Documentation (IEC 62304)
- Risk Management (ISO 14971)
- Design History File (DHF)
- Performance Testing Coordination
- IEC 60601 Electrical Safety
