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U.S. Department of Health and Human Services

Product Classification

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Device femtosecond laser system for refractive correction
Definition Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea.
Physical State The device consists of a laser console, a computer with graphic user interface, a beam delivery system that positions and focuses the laser beam, patient bed, and a patient interface system that flattens the cornea and holds the patient's eye still during the surgical procedure.
Technical Method The laser console generates femtosecond laser pulses. When focused in transparent tissue, these low energy pulses produce photodisruption (a highly localized region of ionized plasma) effects that occur on an extremely short time scale and are confined to the few microns surrounding the focal spot. Patterns of contiguous, focused laser pulses result in the creation of cut surfaces in the cornea that define a disc-shaped tissue (lenticule) in the corneal stroma. The surgeon enters treatment parameters and a corresponding lenticule is created according to a pre-defined algorithm such that its thickness determines the refractive correction and resultant corneal reshaping when extracted.
Target Area Cornea of the eye.
Review Panel Ophthalmic
Product CodeOTL
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 PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible