Lumenis, Ltd.
FDA 510(k) medical device clearances.
Top product codes for Lumenis, Ltd.
Recent clearances by Lumenis, Ltd.
- K212703 — AcuPulse CO2 Laser System, Delivery Devices and Accessories
- DEN200028 — Lumenis Stellar M22
- K203544 — UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
- K202428 — AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
- K201663 — AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
- K193500 — Stellar M22 for Intense Pulsed Light (IPL) and Laser System
- K180597 — AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO
- K170179 — LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
- K170060 — M22 and ResurFx Systems
- K170121 — Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
- 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
- K151947 — LightSheer Desire Light Laser System
- K151331 — The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
- K142860 — Lumenis M22 System
- K133272 — VERSACUT + TISSUE MORCELLATOR
- K133319 — ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060
- K140388 — LUMENIS PULSE 120H
- K130028 — RESURFX 1565NM LASER MODULE
- K130164 — FIBERLASE ENDURE CO2 FIBER
- K100384 — FIBERLASE C02 LASER WAVEGUIDE
- K083733 — LUME 2 SYSTEM, MODEL GA0005000
- K060448 — LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.
- K043173 — Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES
- K040270 — OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM
- K030033 — LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES
- K030342 — LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS
- K024093 — MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS
- K030147 — LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.