Last synced on 25 November 2022 at 11:04 pm

Ophthalmic Femtosecond Laser

Page Type
Product Code
Definition
Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
Physical State
The device consists of a laser console, a computer with grahic user interface, a beam delivery system that positions and focuses the laser beam, and a patient interface system that flattens the cornea and holds the patient's eye still during the surgical procedure.
Technical Method
A Nd:glass solid state laser generates sub-picosecond pulses at a 15 kHz repetition rate. The beam is focused at high convergence to a spot diameter <6 microns at the target location. Tissue is vaporized in a very small region at the focal point. A computer-controlled 3-dimensional scanning system positions the beam with micron-scale accuracy.
Target Area
Anterior lens capsule of the eye.
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.4390
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.4390 Ophthalmic laser

§ 886.4390 Ophthalmic laser.

(a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

(b) Classification. Class II.

Ophthalmic Femtosecond Laser

Page Type
Product Code
Definition
Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
Physical State
The device consists of a laser console, a computer with grahic user interface, a beam delivery system that positions and focuses the laser beam, and a patient interface system that flattens the cornea and holds the patient's eye still during the surgical procedure.
Technical Method
A Nd:glass solid state laser generates sub-picosecond pulses at a 15 kHz repetition rate. The beam is focused at high convergence to a spot diameter <6 microns at the target location. Tissue is vaporized in a very small region at the focal point. A computer-controlled 3-dimensional scanning system positions the beam with micron-scale accuracy.
Target Area
Anterior lens capsule of the eye.
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.4390
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.4390 Ophthalmic laser

§ 886.4390 Ophthalmic laser.

(a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

(b) Classification. Class II.