Lumenis, Inc.

FDA 510(k) & PMA Approved Devices — 42 products

Total Devices42

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K211979	Lumenis Y&R Laser System	GEX	2022-06-21	View
510(k)	K130195	SCANNING LASERLINK	HQF	2013-11-01	View
510(k)	K111213	VISION ONE LASER SYSTEM	GEX	2011-07-25	View
510(k)	K100228	VERSAPULSE MODEL P20 LASER SYSTEM	GEX	2010-02-24	View
510(k)	K091962	POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200	ODF	2009-09-30	View
510(k)	K082809	ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM	GEX	2008-12-18	View
510(k)	K081704	SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS	GEX	2008-09-11	View
510(k)	K053628	LIGHTSHEER DUET LASER SYSTEM	GEX	2006-04-07	View
510(k)	K060338	FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO	GEX	2006-03-09	View
510(k)	K052526	NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES	GEX	2005-11-15	View
510(k)	K051214	ALUMA SKIN RENEWAL SYSTEM	GEI	2005-10-24	View
510(k)	K051944	FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES	HQF	2005-09-30	View
510(k)	K052129	LUMENIS 1000 INTEGRATED SLIT LAMP	GEX	2005-08-30	View
510(k)	K050639	LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM	GCJ	2005-03-31	View
510(k)	K032357	NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES	GEX	2003-10-09	View
510(k)	K022060	LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES	GEX	2002-10-30	View
510(k)	K022327	NOVUS SPECTRA	GEX	2002-10-16	View
510(k)	K020839	QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL	GEX	2002-10-11	View
510(k)	K022181	NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES	GEX	2002-10-01	View
510(k)	K021762	BCLEAR	FTC	2002-08-23	View