Laseroptek Co., Ltd. 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
HELIOS 785 Pico (1754V2)510(k)Feb 7, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Feb 7, 2025
HELIOS 785 Pico510(k)May 22, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 22, 2023
PALLAS Premium510(k)Jan 26, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jan 26, 2023
HELIOS IV 785510(k)Jun 9, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jun 9, 2022
PicoLO Premium510(k)Dec 8, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Dec 8, 2021
PicoLO Nd: YAG Picosecond Laser System510(k)Apr 7, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Apr 7, 2021