Candela Corporation is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Candela Corporation - FDA 510(k) Cleared Devices
Recent clearances: Profound Matrix, Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta), PicoWay Laser System
8
Total
8
Cleared
0
Denied
Candela Corporation has 8 FDA 510(k) cleared medical devices. Based in Wayland, US.
Latest FDA clearance: Jul 2024. Active since 2015. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Candela Corporation Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Candela Corporation
8 devices
Cleared
Jul 01, 2024
Profound Matrix
General & Plastic Surgery
174d
Cleared
Jun 01, 2023
Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
General & Plastic Surgery
56d
Cleared
Oct 13, 2022
PicoWay Laser System
General & Plastic Surgery
204d
Cleared
CT
Dec 20, 2021
Frax 1940 for Nordlys and Frax Pro
General & Plastic Surgery
133d
Cleared
Dec 16, 2021
Profound Matrix
General & Plastic Surgery
237d
Cleared
May 26, 2020
GentleMax Pro Plus
General & Plastic Surgery
29d
Cleared
Sep 16, 2019
PicoWay Laser System
General & Plastic Surgery
84d
Cleared
Apr 16, 2015
PicoWay Laser System
General & Plastic Surgery
66d