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U.S. Department of Health and Human Services

Product Classification

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Device ophthalmic femtosecond laser
Regulation Description Ophthalmic laser.
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
Product CodeOOE
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Diagnostic and Surgical Devices Branch (DSDB)
Submission Type 510(k)
Regulation Number 886.4390
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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