Devices

Device Recall Candela Laser

  • Modèle / numéro de série
    GL Pro Model 9914-00-9015:: SN 9914-9015-0005 through 9914-9015-1259 GL Pro LE Model 9914-00-9040: SN 9914-9040-0716 through 9914-9040-1214
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom.
  • Description du dispositif
    Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. || and Candela Laser GentleLase Pro LE, || Model number: 9914-00-9040
  • Manufacturer
    Candela Corporation
  • 1 Event

Fabricant

Candela Corporation
  • Adresse du fabricant
    Candela Corporation, 530 Boston Post Rd, Wayland MA 01778-1833
  • Société-mère du fabricant (2017)
    Apax Partners Llp
  • Source
    USFDA