Candela Corporation FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Profound Matrix510(k)Jul 1, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jul 1, 2024
Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)510(k)Jun 1, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jun 1, 2023
PicoWay Laser System510(k)Oct 13, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Oct 13, 2022
Frax 1940 for Nordlys and Frax Pro510(k)Dec 20, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Dec 20, 2021
Profound Matrix510(k)Dec 16, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Dec 16, 2021