Lumenis, Inc.
Lumenis, Inc. holds FDA 510(k) medical device clearances, first cleared 1979, most recent 2022, with 3 FDA device recalls on record.
Top product codes for Lumenis, Inc.
FDA recalls by Lumenis, Inc.
- Z-0194-2022 — IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical
- Z-2733-2014 — Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: " Proliferative and Severe and Very Severe Non-Proliferative Diabetic Retinopathy " Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy " Choroidal Neovascularization " Retinal Neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) " Macular Edema associated with Branch Retinal Vein Occlusion " Retinal Tears and Detachments And Anterior Segments as follows: " Iridotomy in Closed Angle Glaucoma " Trabeculoplasty in Open Angle Glaucoma
- Z-2191-2013 — Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Lumenis, Inc.
- K211979 — Lumenis Y&R Laser System
- K151109 — Lumenis Smart532 Laser System
- K130195 — SCANNING LASERLINK
- K111213 — VISION ONE LASER SYSTEM
- K100228 — VERSAPULSE MODEL P20 LASER SYSTEM
- K091962 — POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200
- K082809 — ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
- K081704 — SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
- K053628 — LIGHTSHEER DUET LASER SYSTEM
- K060338 — FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO
- K052526 — NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES
- K051214 — ALUMA SKIN RENEWAL SYSTEM
- K051944 — FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES
- K052129 — LUMENIS 1000 INTEGRATED SLIT LAMP
- K050639 — LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
- K032357 — NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES
- K022060 — LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES
- K022327 — NOVUS SPECTRA
- K020839 — QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL
- K022181 — NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES
- K021762 — BCLEAR
- K004006 — SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER
- K000498 — COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER
- K991258 — NOVUS VERDI DELIVERY SYSTEMS
- K990947 — MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY
- K980685 — MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS
- K980079 — COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES
- K974789 — COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L
- K973470 — COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS
- K972347 — MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER
- K960413 — COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT
- K951812 — MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS
- K946304 — COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES
- K933318 — COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B
- K903689 — COHERENT DIODE PHOTOCOAGULATOR
- K902470 — COHERENT XA30/SP AND XA50 SURGICAL LASERS
- K895518 — COHERENT HOLMIUM:YAG SURGICAL LASER
- K895143 — COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS
- K820327 — MODEL 450XL CO2 SURGICAL LASER
- K812219 — MODEL 900S INTRAOCULAR PROBE
- K810740 — ARGON MICROSURIGAL PROTOCOLS
- K811153 — COHERENT FLOUROTRON MASTER
- K792083 — HAAG-STREIT SLIT LAMP 900
Data sourced from openFDA. This site is unofficial and independent of the FDA.