Manufacturer |
Refractec, Inc, Irvine, California |
Sunrise Technologies, Fremont, California |
Rodenstock; ProLaser Medical Systems, Inc, Dusseldorf, Germany |
Approval status |
FDA approved for 0.75 D to 3.00 D of spherical hyperopia |
FDA approved for 0.75 D to 2.50 D of spherical hyperopia |
Open Investigational Device Exemption |
Type of device/energy delivery |
Radiofrequency energy, 350 kHz, contact probe |
Ho:YAG laser, pulsed 226 to 258 mJ, 5 Hz, noncontact |
Continuous-wave diode laser, contact device |
Wavelength |
Not applicable |
2.1 μm |
1.87 μm |
Temperature during treatment |
Highest at center of cylinder |
Highest on corneal surface |
Radial and axial temperature gradient |
|
Radial (side-to-side) temperature gradient |
Radial and axial temperature gradient |
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No axial (surface to bottom) temperature gradient |
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|
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Consistent thermal effect along the probe |
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Treatment depth |
80% of corneal depth, based on porcine histology |
Wider on surface than in deep stroma |
Not available |
Footprint |
Cylindrical |
Conical |
Conical |
Number of spots |
8, 16, 24, or 32 |
16 to 32 |
In development |
Nomogram adjustment to increase effect |
Increase number of treatment spots |
Increase laser energy/temperature |
Increase number of treatment spots |