Technical Data
ALLEGRETTO WAVE® Excimer Laser
| Laser class | Class 4 (IEC + 21CFR) |
| Laser type | ArF-excimer laser |
| Wavelength | 193 nm |
| Pulse duration | 12 ns |
| Repetition rate | 200 Hz |
| Treatment time | 4 s/D at a fully corrected OZ of 6.5 mm |
| Aiming beam diodes | 635 nm Laser class 2 (IEC 60825), class II (21 CFR 1040) |
| Focusing beam diodes | 635 nm Laser class 2 (IEC 60825), class II (21 CFR 1040) |
| Spot characteristics | Diameter 0.95 mm Gaussian beam profile |
| Ablation profiles | Wavefront Optimized® ablation profiles; |
| Working principle | Flying spot laser system 2 mirrors on closed-loop galvo scanners |
| Eye-tracking system | Active IR eye-tracking system Eye-tracking and laser trigger synchronized Centered on the optical center of the pupil Center manually adjustable |
| Microscope | Zeiss Pico* |
| Magnification steps | 5; 7.5; 12.5; 20; 31.25 |
| Working distance | 20 cm (7.9 inches) |
| Patient adjustment | Z- and xy-adjustment for exact positioning of patients' eye |
| Applications | Wavefront Optimized® refractive treatments Wavefront-guided (A-CAT) treatments in conjunction with the ALLEGRO Analyzer® Device (optional) |
| Refraction increments | 0.25 D (0.01 D) |
| Calibration | Fluence on PMMA and eye-tracking on test targets once a day |
| Energy control | Closed-loop energy control |
| Laser control | Membrane key pad, joystick |
| Gas supply | 1 ArF premix gas cylinder 20 l (integrated) 1 nitrogen gas cylinder (20 l integrated or 50 l external) Nitrogen grade 4.0 or higher |
| Cooling | Air cooled, low noise |
| Weight | Laser with standard bed: 444 kg (979 pounds) (excl.gas) Laser with swiveling bed: 476 kg (1,050 pounds) (excl. gas) |
| Power Requirements | |
| Mains connection | 208 - 240 V single phase 50 Hz ± 5%, 16 A |
| Power consumption | Laser console (in operation): 1.0 kW (max. 3.2 kW) Laser console (in standby): 0.3 kW Patient bed: 0.6 kW Plume evacuator: 1.2 kW |
| Operating conditions | |
| Space requirements | Laser with standard bed (L x W x H): 250 x 150 x 130 cm 98 x 59 x 51 inches) Laser with swiveling bed (L x W x H): 250 x 220 x 130 cm (98 x 86 x 51 inches) |
| Static requirements | Capacity > 500 kg/m2 (1,103 pounds/10.8 sq foot) |
| Temperature range | 18 - 30°C (65 - 86°F) |
| Humidity | 20 - 70% at 25°C (77°F), not condensing |
| Air condition | 1.5 kW thermal output to be carried off |
| Ventilation | Ventilation of min. 100 m3 (131 yards3) required |
| Integrated Accessories | Optional Accessories |
| Patient bed | Swiveling patient bed |
| Laser gas premix ArF | Laser safety spectacles |
| Ablation depth micrometer | Uninterrupted power supply (110 V / 60 Hz or 230 V / 50 Hz) |
| TFT eye-tracking monitor | Sterile covers |
| Notebook computer | Sterile sets |
| Advanced microscope system | Video system for observing and recording the treatment |
| External nitrogen connection | Surgeon's chair with or without armrests |
| Plume evacuator | |
| Fiber optic slit projector with light source (slit lamp) | |
| Compliance | |
| In compliance with | Medical Device Directive (MDD) 93/42/EEC, IEC 60601/IEC 60825 |
| Certified by | LGA InterCert notified body no. 1275 |
| Electrical safety class | Class I, type B |
| Medical device class | Class IIb according MDD |
| US approval (PMA) by Food and Drug Administration (FDA) | PMA no. P030008 (Hyperopia and Mixed Astigmatism) PMA no. P020050 (Myopia with and without Astigmatism) |
Specifications are subject to change.
*Trademarks(s) are the property of their respective owner(s).
Myopia:
a. Approval of the premarket approval application is for the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System to perform LASIK treatments in patients 18 years of age or older for the reduction or elimination of myopic refractive errors up to -12.0 diopters (D) of sphere with and without astigmatic refractive errors up to -6.0 D; and in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery.
b. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries.
c. Approval of the application is based on clinical trials in the United States with 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%.
d. The studies found that of the 844 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 98.0% were corrected to 20/40 or better, and 84.4% were corrected to 20/20 or better without spectacles or contact lenses.
e. The clinical trials showed that the following subjective patient adverse events were reported as “moderate to severe” at a level at least 1% higher than baseline of the subjects at 3 months posttreatment: visual fluctuations (12.8% at baseline versus 28.6% at 3 months).
f. Long-term risks of LASIK for myopia with and without astigmatism beyond 12 months have not been studied.
g. Note that the complete name for this ophthalmic laser is “WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System for laser assisted in-situ keratomileusis (LASIK) treatments of myopic refractive errors up to -12.0 diopters (D) of sphere with and without astigmatic refractive errors up to -6.0 D at the spectacle plane.”
Hyperopia:
a. Approval of the premarket approval application is for the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System to perform LASIK treatments in patients 18 years of age or older for the reduction or elimination of hyperopic refractive errors up to +6.0 diopters (D) of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D; and in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia.
b. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries.
c. Approval of the application is based on clinical trials in the United States with 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%.
d. The studies found that of the 212 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 67.5% were corrected to 20/20 or better without spectacles or contact lenses.
e. The study showed that the following subjective patient adverse events were reported as “much worse” by at least 1% of the subjects (in order of increasing frequency) at 6 months post final treatment: glare from bright lights (3.0%); night driving glare (4.2%) light sensitivity (4.9%); visual fluctuations (6.1%); and halos (6.4%).
f. Long term risks of LASIK for hyperopia with and without astigmatism beyond 12 months have not been studied.
g. Note that the complete name for this ophthalmic laser is “WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System for laser assisted in-situ keratomileusis (LASIK) treatments of hyperopic refractive errors up to +6.0 diopters (D) of sphere with and without astigmatic refractive errors up to 5.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D.”
Mixed Astigmatism:
a. Approval of the premarket approval application is for the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System to perform LASIK treatments in patients 21 years of age or older for the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane; and in patients with documentation of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery.
b. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries.
c. Approval of the application is based on clinical trials in the United States with 162 eyes treated, of which 111 were eligible to be followed at 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%.
d. The studies found that of the 142 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 95.8% achieved acuity of 20/40 or better, and 67.6% achieved acuity of 20/20 or better without spectacles or contact lenses.
e. The clinical trials showed that the following subjective patient adverse events were reported as “moderate to severe” at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: sensitivity to light (43.3% at baseline versus 52.9% at 3 months); visual fluctuations (32.1% at baseline versus 43.0% at 3 months); and halos (37.0% at baseline versus 42.3% at 3 months).
f. Long term risks of LASIK for mixed astigmatism beyond 6 months have not been studied.
g. The safety and effectiveness of LASIK surgery has ONLY been established with an optical zone of 6.0 - 7.0 mm and an ablation zone of 9.0 mm.
h. Note that the complete name for this ophthalmic laser is “WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System for laser assisted in-situ keratomileusis (LASIK) treatments of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane.”
Wavefront-Guided Treatment of Myopia:
a. Approval of the premarket approval application is for the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System used in conjunction with the WaveLight® ALLEGRO Analyzer® device. The device uses a 6.5 mm optical zone, a 9.0 mm ablation/treatment zone, and is indicated for wavefront-guided (WFG) laser assisted in-situ keratomileusis (LASIK): 1) for the reduction or elimination of up to -7.00 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery.
b. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), traditional LASIK and other refractive surgeries.
c. Approval of the application is based on a randomized clinical trial in the United States with 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized® LASIK (Control Cohort). 178 of the Study Cohort and 180 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%.
d. The studies found that of the 180 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point in the Study Cohort, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better without spectacles or contact lenses. In the Control Cohort, of the 176 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 92.8% were corrected to 20/20 or better without spectacles or contact lenses.
e. The clinical trials showed that the following subjective patient adverse events were reported as “moderate to severe” at a level at least 1% higher than baseline of the subjects at 3 months post-treatment in the Study Cohort, light sensitivity (37.2% at baseline versus 47.8% at 3 months) and visual fluctuations (13.8% at baseline versus 20.0% at 3 months). In the Control Cohort, halos (36.6% at baseline versus 45.4% at 3 months) and visual fluctuations (18.3% at baseline versus 21.9% at 3 months).
f. Long term risks of wavefront-guided LASIK for myopia with and without astigmatism beyond 6 months have not been studied.
g. Note that the complete name for this ophthalmic laser is “WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System used in conjunction with the WaveLight® ALLEGRO Analyzer® device. The device uses a 6.5 mm optical zone, a 9.0 mm ablation/treatment zone, and is indicated for wavefront-guided (WFG) laser-assisted in-situ keratomileusis (LASIK): 1) for the reduction or elimination of up to -7.00 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery.”