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Lumenis, Ltd.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories2
Latest Approval2021-10-19
TypeNumberDevice NameCodeDate
510(k) K212703 AcuPulse CO2 Laser System, Delivery Devices and Accessories GEX 2021-10-19 View
510(k) DEN200028 Lumenis Stellar M22 QIU 2021-02-23 View
510(k) K203544 UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories GEX 2020-12-24 View
510(k) K202428 AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories GEX 2020-10-22 View
510(k) K201663 AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories GEX 2020-07-16 View
510(k) K193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser System GEX 2020-01-16 View
510(k) K180597 AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO GEX 2018-04-03 View
510(k) K170179 LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity GEX 2017-09-18 View
510(k) K170060 M22 and ResurFx Systems GEX 2017-08-09 View
510(k) K170121 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories GEX 2017-05-22 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 System GEX 2017-02-28 View
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