COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
LUMENIS, INC.
LUMENIS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1720381 | 1720381 | LUMENIS, INC. | 1 | Y | 2020-04-25 | 1870 S Milestone Dr SALT LAKE CITY UT US 84104 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 15657 | 1871548197 | 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 |
| 15657 | 2022469672 | K151109 | Lumenis Smart532 Laser System | GEX | 2015-10-30 |
| 15657 | 1049975379 | K130195 | SCANNING LASERLINK | HQF | 2013-11-01 |
| 15657 | 1201089207 | K111213 | VISION ONE LASER SYSTEM | GEX | 2011-07-25 |
| 15657 | 1049606527 | K081704 | SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS | GEX | 2008-09-11 |
| 15657 | 1726182248 | K022327 | NOVUS SPECTRA | GEX | 2002-10-16 |
| 15657 | 1425721076 | K004006 | SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER | GEX | 2001-03-26 |
Product Codes Associated With Registrations#
PMA#
PMN#
Lumenis Y&R Laser System
Lumenis, Inc.
Lumenis Smart532 Laser System
LUMENIS, INC.
SCANNING LASERLINK
LUMENIS, INC.
VERSAPULSE MODEL P20 LASER SYSTEM
Lumenis, Inc.
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200
LUMENIS, INC.
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
LUMENIS, INC.
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
LUMENIS, INC.
LIGHTSHEER DUET LASER SYSTEM
LUMENIS, INC.
FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO
LUMENIS, INC.
NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES
LUMENIS, INC.
ALUMA SKIN RENEWAL SYSTEM
LUMENIS, INC.
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES
LUMENIS, INC.
LUMENIS 1000 INTEGRATED SLIT LAMP
LUMENIS, INC.
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
LUMENIS, INC.
NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES
LUMENIS, INC.
LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES
LUMENIS, INC.
NOVUS SPECTRA
LUMENIS, INC.
QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL
LUMENIS, INC.
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES
LUMENIS, INC.
BCLEAR
LUMENIS, INC.
SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER
LUMENIS, INC.
COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER
LUMENIS, INC.
NOVUS VERDI DELIVERY SYSTEMS
LUMENIS, INC.
MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY
LUMENIS, INC.
MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS
LUMENIS, INC.
COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES
LUMENIS, INC.
COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L
LUMENIS, INC.
COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS
LUMENIS, INC.
MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER
LUMENIS, INC.
COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT
LUMENIS, INC.
MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS
LUMENIS, INC.
COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES
LUMENIS, INC.
COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B
LUMENIS, INC.
COHERENT DIODE PHOTOCOAGULATOR
LUMENIS, INC.
COHERENT XA30/SP AND XA50 SURGICAL LASERS
LUMENIS, INC.
COHERENT HOLMIUM:YAG SURGICAL LASER
LUMENIS, INC.
COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS
LUMENIS, INC.
MODEL 450XL CO2 SURGICAL LASER
LUMENIS, INC.
MODEL 900S INTRAOCULAR PROBE
LUMENIS, INC.
ARGON MICROSURIGAL PROTOCOLS
LUMENIS, INC.