Lumenis, Ltd. FDA Approvals

0 new drug approvals and 2 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
AcuPulse CO2 Laser System, Delivery Devices and Accessories510(k)Oct 19, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Oct 19, 2021
Lumenis Stellar M22510(k)Feb 23, 2021Ophthalmic	Ophthalmic	510(k)Unknown (Direct)	Feb 23, 2021