Lumenis, Ltd.
FDA 510(k) & PMA Approved Devices — 10 products
Total Devices10
Categories1
Latest FDA decision2021-10-19
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | GEX | 2021-10-19 | 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 |
No matching devices.