FDA 510(k) Applications Submitted by Candela Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K191685 06/24/2019 PicoWay Laser System Candela Corporation
K220853 03/23/2022 PicoWay Laser System Candela Corporation
K230990 04/06/2023 Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) Candela Corporation
K211217 04/23/2021 Profound Matrix Candela Corporation
K212492 08/09/2021 Frax 1940 for Nordlys and Frax Pro Candela Corporation
K150326 02/09/2015 PicoWay Laser System Candela Corporation
K201111 04/27/2020 GentleMax Pro Plus Candela Corporation


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