FDA 510(k) Applications Submitted by LUMENIS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020839 |
03/15/2002 |
QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL |
LUMENIS, INC. |
| K980079 |
01/09/1998 |
COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES |
LUMENIS, INC. |
| K960413 |
01/29/1996 |
COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT |
LUMENIS, INC. |
| K980685 |
02/23/1998 |
MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS |
LUMENIS, INC. |
| K972347 |
06/24/1997 |
MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER |
LUMENIS, INC. |
| K022060 |
06/25/2002 |
LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES |
LUMENIS, INC. |
| K021762 |
05/29/2002 |
BCLEAR |
LUMENIS, INC. |
| K060338 |
02/10/2006 |
FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO |
LUMENIS, INC. |
| K051214 |
05/12/2005 |
ALUMA SKIN RENEWAL SYSTEM |
LUMENIS, INC. |
| K053628 |
12/29/2005 |
LIGHTSHEER DUET LASER SYSTEM |
LUMENIS, INC. |
| K100228 |
01/26/2010 |
VERSAPULSE MODEL P20 LASER SYSTEM |
LUMENIS, INC. |
| K000498 |
02/15/2000 |
COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER |
LUMENIS, INC. |
| K082809 |
09/24/2008 |
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM |
LUMENIS, INC. |
| K130195 |
01/28/2013 |
SCANNING LASERLINK |
LUMENIS, INC. |
| K151109 |
04/27/2015 |
Lumenis Smart532 Laser System |
LUMENIS, INC. |
| K032357 |
07/30/2003 |
NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES |
LUMENIS, INC. |
| K973470 |
09/12/1997 |
COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS |
LUMENIS, INC. |
| K004006 |
12/26/2000 |
SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER |
LUMENIS, INC. |
| K022181 |
07/03/2002 |
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES |
LUMENIS, INC. |
| K051944 |
07/18/2005 |
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES |
LUMENIS, INC. |
| K052129 |
08/05/2005 |
LUMENIS 1000 INTEGRATED SLIT LAMP |
LUMENIS, INC. |
| K052526 |
09/14/2005 |
NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES |
LUMENIS, INC. |
| K991258 |
04/13/1999 |
NOVUS VERDI DELIVERY SYSTEMS |
LUMENIS, INC. |
| K022327 |
07/18/2002 |
NOVUS SPECTRA |
LUMENIS, INC. |
| K050639 |
03/14/2005 |
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM |
LUMENIS, INC. |
| K974789 |
12/22/1997 |
COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L |
LUMENIS, INC. |
| K990947 |
03/22/1999 |
MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY |
LUMENIS, INC. |
| K091962 |
07/01/2009 |
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 |
LUMENIS, INC. |
| K081704 |
06/17/2008 |
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS |
LUMENIS, INC. |
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