Device Recall Surgical Laser Technologies, Inc. (SLT) SSRH

  • 모델명 / 제조번호(시리얼번호)
    Lot number 226201
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom.
  • 제품 설명
    The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. || The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. || Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    PhotoMedex, Inc., 147 Keystone Dr, Montgomeryville PA 18936-9638
  • 제조사 모회사 (2017)
  • Source
    USFDA