FDA approval:
SANTA CLARA, Calif.--(BW HealthWire)--May 3, 2000--VISX,
INCORPORATED (Nasdaq:VISX.O) announced today that the U.S. Food and
Drug Administration (FDA) has granted 510(k) clearance for its VISX
WaveScan(TM) Wavefront System.
The VISX WaveScan Wavefront System is the only FDA-approved system
that allows physicians to instantly measure refractive aberrations
using highly advanced optics. The optics project light into the eye
and precisely analyze the returning wavefront using a Hartmann-Shack
sensor containing thousands of tiny lenslets. From the system,
surgeons will obtain a WavePrint(TM), much like a "fingerprint" of the
eye, which illustrates an accurate assessment of the patient's
refractive errors. The company expects the VISX WaveScan system to be
commercially available later this year.
Liz Davila, President and Chief Operating Officer of VISX,
commented, "This is another first for VISX and we are delighted. We
intend to move quickly to get the technology into the hands of all
VISX customers. Precise measurement of refractive errors has always
been the key element in achieving excellent laser vision correction
outcomes. |
