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Candela Corporation

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories2
Latest FDA decision2024-07-01
TypeNumberDevice NameCodeDateActions
510(k) K240070 Profound MatrixGEI2024-07-01 View
510(k) K230990 Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)GEX2023-06-01 View
510(k) K220853 PicoWay Laser SystemGEX2022-10-13 View
510(k) K212492 Frax 1940 for Nordlys and Frax ProGEX2021-12-20 View
510(k) K211217 Profound MatrixGEI2021-12-16 View
510(k) K201111 GentleMax Pro PlusGEX2020-05-26 View
510(k) K191685 PicoWay Laser SystemGEX2019-09-16 View
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