FDA 510(k) Applications Submitted by Dario Bandiera

FDA 510(k) Number Submission Date Device Name Applicant
K220426 02/14/2022 Fiber Dust PRO Quanta System Spa
K240983 04/10/2024 Discovery Pico; Discovery Pico Plus; Discovery Pico Derm Quanta System SpA
K241092 04/22/2024 Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT Quanta System S.p.A.
K201382 05/26/2020 X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) de Gotzen S.r.l.
K191719 06/26/2019 X-MIND Trium de Gotzen S.R.L
K232236 07/27/2023 Echo Quanta System Spa
K192165 08/09/2019 Acteon Imaging Suite de Gotzen S.R.L
K223404 11/09/2022 Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V Quanta System, S.p.A.
K203374 11/16/2020 X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) de G÷tzen S.r.l.
K243588 11/20/2024 Single Use CO2 Laser Fiber (HAF005001) Quanta System SpA


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