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Azena Medical, LLC

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories2
Latest FDA decision2026-03-10
TypeNumberDevice NameCodeDateActions
510(k) K260765 Gemini NOVA 810+980 Soft Tissue LaserNVK2026-03-10 View
510(k) K210350 Gemini 2 810+980 Soft Tissue LaserNVK2021-11-18 View
510(k) K192617 Gemini 810+980 Soft Tissue LaserGEX2020-02-20 View