Lumenis Be, Ltd. FDA Approvals

0 new drug approvals and 7 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
SmartIPL_NI System510(k)Sep 19, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Sep 19, 2026
MILAN System510(k)Jun 2, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jun 2, 2026
Stellar M22510(k)Apr 16, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Apr 16, 2025
FoLix510(k)Sep 9, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Sep 9, 2024
ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories510(k)Dec 1, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Dec 1, 2023
F65 Laser System510(k)Jun 14, 2023Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Jun 14, 2023
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories510(k)May 18, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 18, 2022