Cynosure, LLC FDA Approvals

0 new drug approvals and 6 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
PICOSURE WORKSTATION510(k)Jun 17, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Jun 17, 2026
Elite iQ PRO (M122K1)510(k)Mar 8, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Mar 8, 2024
MyEllevate510(k)Jul 6, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jul 6, 2023
TempSure System510(k)Nov 23, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Nov 23, 2022
TempSure System510(k)Mar 18, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Mar 18, 2022
PicoSure Workstation510(k)Mar 30, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Mar 30, 2021