Candela Corporation is one of 16073 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.
510(k) submissions have been managed by Hogan Lovells US LLP as regulatory consultant. 2 devices have linked clinical trials 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
CT
Apr 16, 2015
PicoWay Laser System
General & Plastic Surgery
66d