LUMENIS BE INC. FDA Filings

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3020611964	1720381	LUMENIS BE INC.	1	Y	2026-01-01	1870 South Milestone Drive Salt Lake City UT US 84104

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
296728	1612946485	K220877	Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems	HQF	2022-07-15
296728	1152906462	K162837	Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System	GEX	2017-02-28
296728	1781816263	K151109	Lumenis Smart532 Laser System	GEX	2015-10-30
296728	1302129895	K111213	VISION ONE LASER SYSTEM	GEX	2011-07-25

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GEX	3	2017-02-28
HQF	1	2022-07-15