Device Recall Candela Laser

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 1 Event

제조사

  • 제조사 주소
    Candela Corporation, 530 Boston Post Rd, Wayland MA 01778-1833
  • 제조사 모회사 (2017)
  • Source
    USFDA