Lumenis, Inc. - FDA 510(k) Cleared Devices
43
Total
43
Cleared
0
Denied
Lumenis, Inc. has 43 FDA 510(k) cleared general & plastic surgery devices. Based in Mchenry, US.
Last cleared in 2022. Active since 1979.
Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Kathy Maynor as regulatory consultant.
43 devices
Cleared
Jun 21, 2022
Lumenis Y&R Laser System
General & Plastic Surgery
361d
Cleared
Oct 30, 2015
Lumenis Smart532 Laser System
General & Plastic Surgery
186d
Cleared
Nov 01, 2013
SCANNING LASERLINK
Ophthalmic
277d
Cleared
Jul 25, 2011
VISION ONE LASER SYSTEM
General & Plastic Surgery
84d
Cleared
Feb 24, 2010
VERSAPULSE MODEL P20 LASER SYSTEM
General & Plastic Surgery
29d
Cleared
Sep 30, 2009
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER
Gastroenterology & Urology
91d
Cleared
Dec 18, 2008
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
General & Plastic Surgery
85d
Cleared
Sep 11, 2008
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
Ophthalmic
86d
Cleared
Apr 07, 2006
LIGHTSHEER DUET LASER SYSTEM
General & Plastic Surgery
99d
Cleared
Mar 09, 2006
FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA...
General & Plastic Surgery
27d
Cleared
Nov 15, 2005
NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES
General & Plastic Surgery
62d
Cleared
Oct 24, 2005
ALUMA SKIN RENEWAL SYSTEM
General & Plastic Surgery
165d
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