INTRALASE FS Laser

  • Model / Serial
    All units of these models (models 2, 3 and iFS) except model 1.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Product Description
    Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K; || Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA || Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.
  • Manufacturer
  • 3 Events

Manufacturer

  • Manufacturer Address
    AMO Manufacturing USA, LLC, 510 Cottonwood Dr, Milpitas CA 95035-7403
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

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