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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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