Lumenis, Ltd.
Lumenis, Ltd. holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2021, with 3 FDA device recalls on record.
Top product codes for Lumenis, Ltd.
FDA recalls by Lumenis, Ltd.
- Z-2344-2025 — OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
- Z-1290-2025 — (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
- Z-1669-2016 — Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
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) +1 more
- 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.