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Lumenis, Ltd.

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K212703 AcuPulse CO2 Laser System, Delivery Devices and AccessoriesGEX2021-10-19 View
510(k) K203544 UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesGEX2020-12-24 View
510(k) K202428 AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesGEX2020-10-22 View
510(k) K201663 AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesGEX2020-07-16 View
510(k) K193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemGEX2020-01-16 View
510(k) K180597 AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOGEX2018-04-03 View
510(k) K170179 LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityGEX2017-09-18 View
510(k) K170060 M22 and ResurFx SystemsGEX2017-08-09 View
510(k) K170121 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesGEX2017-05-22 View
510(k) K162837 Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser SystemGEX2017-02-28 View
510(k) K130028 RESURFX 1565NM LASER MODULEONG2013-09-03 View
510(k) K130164 FIBERLASE ENDURE CO2 FIBERGEX2013-03-24 View
510(k) K100384 FIBERLASE C02 LASER WAVEGUIDEGEX2010-04-12 View
510(k) K083733 LUME 2 SYSTEM, MODEL GA0005000GEX2009-05-04 View
510(k) K060448 LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.GEX2006-07-06 View
510(k) K043173 Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIESGEX2005-01-31 View
510(k) K040270 OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUMGEX2004-12-16 View
510(k) K030033 LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICESGEX2003-07-21 View
510(k) K030342 LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMSGEX2003-07-17 View
510(k) K024093 MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMSGEX2003-06-19 View
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