Lumenis

  • Model / Serial
    Software versions lower than 2.02 All serial numbers; All codes
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was released for distribution to 124 consignees nationwide. One international consignee includes: New Zealand. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Product Description
    Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13 Hayetzira Street, Yokneam Industrial Park, Yokneam, Israel 20692
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Lumenis Inc., 2400 Condensa St, Santa Clara CA 95051-0901
  • Source
    USFDA

17 devices with a similar name

Learn more about the data here

  • Model / Serial
    LIGHTSHEER DESIRE, serial all systems with XC handpiece.
  • Product Description
    Destined for temporary hair removal, or long-term or permanent hair reduction, by selective application to melanin of the hair follicles. Used for pseudofolliculitis, treatment of varicose veins, benign vascular lesions, angiomas, hemangiomas and telangiectasia
  • Manufacturer
  • Model / Serial
    AcuPulse DUO CO2, AcuPulse and AcuScan120, concerning the FemTouch Kit and FemTouch Handpiece systems.
  • Product Description
    The CO2 laser can be used effectively in soft tissue removal, incision, ablation, vaporization and coagulation. This CO2 laser system excited by DC (direct current) is designed for various procedures, aesthetic, surgical and general surgery.
  • Manufacturer
  • Model / Serial
    Model: All models, Affected: All lots
  • Manufacturer
  • Model / Serial
    GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System with Regular H/P). Only the hand pieces for the system (SA4769200 inverted HP, SA4768700 regular HP) are affected by this recall.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including CA, PA, MA, FL, and NY, and Internationally to Italy, Germany, Australia, China, Great Britian, United Kingdom, Taiwan, France, Peru, Mexico, Turkey, Spain, and Russia.
  • Product Description
    Lumenis VersaCut+ Tissue Morcellator GA-0007500 || The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
  • Manufacturer
12 more