Device Recall EC5000 Excimer Laser Corneal Surgery System

  • Model / Serial
    Alll devices currently in use by consignees.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Us distribution only.
  • Product Description
    EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. || Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • Manufacturer Parent Company (2017)
  • Source
    USFDA