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- Country
- United States
- Address
- 1870 S. Milestone Dr, Salt Lake city, UT, United States
- Website
- lumenis.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Karen Smith
- EUDAMED SRN
- US-MF-000016037
- FDA FEI Number
- —
- DUNS Number
- 118292380
Catalogue (63)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Endo kit with Fixed Eye Safety Filter | Endo kit with Fixed 532/577/659 nm | FDA UDI | Class II | Active |
| LightSheer Desire Light | NA | FDA UDI | Class II | Unknown |
| SurgiTouch™ Scanning Handpiece 200mm | NA | FDA UDI | Class II | Active |
| LightSheer® Duet ET™ Handpiece | NA | FDA UDI | Class II | Active |
| SurgiTouch™ Scanning Handpiece 125mm | NA | FDA UDI | Class II | Active |
| Focused Incisional Handpiece Set | NA | FDA UDI | Class II | Active |
| Vision One | G/Y/R | FDA UDI | Class II | Active |
| OptiLight™ Aesthetics | OptiLight Aesthetics | FDA UDI | Class II | Active |
| Vision One | G/R | FDA UDI | Class II | Active |
| Vision One | Red | FDA UDI | Class II | Active |
| LightSheer Desire, Basic | NA | FDA UDI | Class II | Unknown |
| Stellar M22™ ResurFX™ Module | NA | FDA UDI | Class II | Active |
| RFUTE Handpiece Upgrade | RFUTE Handpiece Upgrade | FDA UDI | Class II | Unknown |
| LightSheer Duet, with ET and HS Handpieces | NA | FDA UDI | Class II | Unknown |
| FoLix™ | NA | FDA UDI | Class II | Active |
| Fixed Eye Safety Filter | Fixed Eye Safety Filter 532/577/659 nm | FDA UDI | Class II | Active |
| TrueSpot™ 2.0mm Handpiece | NA | FDA UDI | Class II | Active |
| Vision One | Y/R | FDA UDI | Class II | Active |
| LUSTER Handpiece | NA | FDA UDI | Class II | Unknown |
| Automatic Eye Safety Filter | Automatic Eye Safety Filter 532nm | FDA UDI | Class II | Active |
| DeepFX ™ Microscanner | NA | FDA UDI | Class II | Active |
| LUSTER System | NA | FDA UDI | Class II | Unknown |
| M22 IPL "VA" Filter | NA | FDA UDI | Class II | Active |
| Vision One | Yellow | FDA UDI | Class II | Active |
| AcPulse W | NA | FDA UDI | Class II | Active |
| Stellar M22™ | Stellar M22™ RFX | FDA UDI | Class II | Active |
| DeepFX™ Microscanner | NA | FDA UDI | Class II | Active |
| SurgiTouch™ Scanning Handpiece Set | NA | FDA UDI | Class II | Active |
| Vision One | G/Y | FDA UDI | Class II | Active |
| Multi-Spot Nd:YAG Lightguide 1.5mm Tip | Multi-Spot Nd:YAG Lightguide 1.5mm Tip | FDA UDI | Class II | Active |
| DeepFX ™ Microscanner | NA | FDA UDI | Class II | Active |
| FoLix™ Handpiece | NA | FDA UDI | Class II | Active |
| 90° Mirror Tip for Multi-Application Ha | NA | FDA UDI | Class II | Active |
| Array LaserLink | NA | FDA UDI | Class II | Active |
| Laser Link HS | Laser Link HS 532/577/659nm | FDA UDI | Class II | Active |
| Fixed Eye Safety Filter | Fixed Eye Safety Filter 532 nm | FDA UDI | Class II | Active |
| 120° Mirror Tip for Multi-Application Ha | NA | FDA UDI | Class II | Active |
| Endo kit with Fixed Eye Safety Filter | Endo kit with Fixed ESF 532 nm | FDA UDI | Class II | Active |
| Endo kit with Automatic Eye Safety Filter | Endo kit with Auto ESF 532 nm | FDA UDI | Class II | Active |
| LUSTER Tip, Round | NA | FDA UDI | Class II | Unknown |
| Digital OptiLight Aesthetics | NA | FDA UDI | Class II | Active |
| NAFR Tips | NAFR Tips | FDA UDI | Class II | Unknown |
| FoLiCool™ Tip | NA | FDA UDI | Class II | Active |
| UltraScan CPG | NA | FDA UDI | Class II | Active |
| OptiSet™ | OptiSet™ | FDA UDI | Class I | Active |
| UltraScan CPG | NA | FDA UDI | Class II | Active |
| SurgiTouch™ Scanning Handpiece 260mm | NA | FDA UDI | Class II | Active |
| M22 IPL "AC" Filter | NA | FDA UDI | Class II | Active |
| Automatic Eye Safety Filter | Automatic Eye Safety Filter 532/577/659 nm | FDA UDI | Class II | Active |
| Smart-V Illumination Add-on | Smart-V Illumination Add-on | FDA UDI | Class II | Active |
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