Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
* In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea * In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments * In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal * In lamellar IEK and corneal harvesting * In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea * In the creation of a lamellar cut/resection of the cornea for lamellar [EK and for the creation of a penetrating cut/incision for penetrating IEK * In patients undergoing ophthalmic surgery or other treatment requiring the creation of corneal channel for placement/insertion of a corneal inlay device
In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments. In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal. In lamellar IEK and corneal harvesting. In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar [EK and for the creation of a penetrating cut/incision for penetrating IEK. In patients undergoing ophthalmic surgery or other treatment requiring the creation of corneal channel for placement/insertion of a corneal inlay device.
The iFS Laser System is a powered laser surgical instrument that delivers femtosecond pulses through a computer-controlled delivery system to produce a pattern of photodisruption to create cuts/separation in ophthalmic tissue. The device shares the same design principle and mode of operation as the predicate devices, utilizing a suction vacuum to affix a suction ring to the corneal surface prior to use. Software updates were made to include the addition of an inlay channel pattern and the associated graphical user interface functionality. The system underwent medical electrical equipment testing and was in compliance with applicable safety standards.
Summary parsed at:2026-06-01 06:10:11 UTC
