Role: Product Manager · Design & Development · 510(k) author
What It Is
GentleBeam™ (SkinCure Oncology) is an FDA-cleared advanced visualization tool for Image-Guided Superficial Radiation Therapy (IGSRT) used to treat nonmelanoma skin cancer in dermatology practices. It uses Photosonic™ technology, laser-induced acoustic pressure waves, to visualize skin layers and blood vessels, sharpening treatment planning, daily dose delivery, and confirmation of tumor eradication.
Why It Matters
Image-guided superficial radiation brings hospital-grade precision into the dermatology setting. Published studies referenced by SkinCure report cure rates exceeding 99% for appropriately selected nonmelanoma skin cancers, with more than 140,000 patients treated nationwide across roughly 500 physicians, at a far lower cost than traditional hospital-based electron-beam therapy.
Role
Ran design and development as the product manager, authored the entire 510(k) submission, and submitted it to the FDA. The device received 510(k) clearance under K250692.