� �

wer

bers

buer

o.de

· 02

/06

our vision is the future

WaveLight AGAm Wolfsmantel 591058 Erlangen, Germany

WaveLight S.A.C/Herrerías, 2228760 Tres Cantos, Madrid, Spain

WaveLight, Inc.46040 Center Oak PlazaSterling, VA 20166, U.S.A.

www.wavelight-laser.com

WaveLight Ophthalmology

International Version

� �

On the forefront of technology with WaveLight

WaveLight is the leader in the development of

innovative diagnostic and surgical technologies for

better vision.

From wavefront- to asphericity-guided laser vision

correction, we have brought the most cutting

edge technologies to the refractive market in the

past six years.

And, we are more committed than ever to con-

tinue our research for even better ways to improve

your practice and provide patients with more

safety, precision and quality.

If you are looking for a partner rather than a

technology provider, your search is over. With

WaveLight, you can stay on the forefront of

technology, while improving your workflow and

reducing costs.

Choose from the largest product portfolio in re-

fractive laser surgery to customize your practice

exactly to your needs.

Our dedicated team of experts in clinical appli-

cation, technical support and research is ready to

work with you. Right. From the Start.

· More than 250 employees in Germany,

the US, Spain and France

· Publicly traded on the German stock

exchange since 1999

· Installed base of more than 600 laser

systems and 300 diagnostic devices

Commitment · Competence · Communication

� �

Process-oriented solutions for your practice

From diagnostics to treatment and post sale

service and support: WaveLight offers a wide

range of solutions for your practice. You can

choose from several products for every segment

of the surgery process and customize technology

precisely to your needs.

This also provides you with maximum flexibility,

as you can always integrate additional technology

over time; based on your experience, financial

considerations, and marketing objectives.

The Circle of Excellence

WaveLight DIAGNOSIS

WaveLight SUPPORT

WaveLight TREATMENT

WaveLight CUSTOMIZATION

� �

State-of-the-Art Manufacturing

Since November 2004 all medical products from

WaveLight have been manufactured in the cus-

tom built production facility in Pressath, Southern

Germany.

The new modular production floor is one of the

first state-of-the-art facilities of this kind in Europe.

Here, WaveLight systems are manufactured under

the highest possible technological standards.

Several regulatory authorities, including the

U.S. Food and Drug Administration (FDA) and

the German Landesgewerbeanstalt (LGA) have

successfully audited the facility for consistent

and safe production in accordance with their

regulations, and issued positive certifications

for our manufacturing processes.

Production site Pressath, Germany

� �

Treat more patients

+6

+6

-6

-6 +3-14

Cylinder

Sphere

0-3-9

-3

+3

Convert cylinder intoplus notation

Treatment range depends on VD and optical zone

Expanded Treatment Range

Treatment indications*:

· Myopia up to -14D

· Hyperopia up to + 6D

· Astigmatism up to +/- 6 D

· Mixed astigmatism

· Irregular corneas

· Corneal scars

· Aberrations

· Decentrations

· Small optical zones

· Presbyopia (Monovision and Custom Q)

*(indications may vary based on technology andpatient characteristics)

With a range of diagnostic and customization

tools, WaveLight enables you to treat the widest

range of clinical indications from high myopia to

corneal scars.

Our high precision technology keeps re-treatments

at a minimum, providing you with more time to

focus on your practice.

If a patient is qualified for refractive surgery, tech-

nology should not be an obstacle for treatment.

That is why ALLEGRETTO WAVE lasers come with

a reliable eyetracker that follows even large pupils

and perform tissue friendly ablations with the

wavefront-optimized algorithm.

WaveLight Treatment Range

� �

Accuracy ensures satisfied patients and the

uninterrupted performance of your clinic.

WaveLight’s exact diagnostics, carefully tailored

treatment methods, and high precision laser

technology provide for outcomes that meet

expectations.

Furthermore, the once-a-day calibration routine

ensures a smooth and reliable performance of the

laser and shortens preparation times.

With an improved workflow, more precise

outcomes and a wider treatment spectrum you

can effectively improve the bottom line of your

practice – even more so since WaveLight does

not charge additional per procedure fees.

Improve the bottom line

Accurate results with:

· High precision calibration routine

· Smart energy control for stable energy delivery

· Advanced fast track eyetracking system for

accurate placement of laser pulses

· Integrated nomogram adjustment based on

FDA clinical trial results

Meeting Expectations

New technology reduces re-treatments

Enhancement rate (%)

Previous platform WaveLight

Model. Results may vary.

WaveLight withnomogram optimization

15%

10%

5%

� �

The acquisition of a WaveLight system is only the

beginning of a long-term partnership.

Our competent support is committed to provide

you and your patients with the highest standards

in clinical application and technical performance.

In addition, our practice development program

for patient marketing and education supports the

successful integration of our technologies into

your clinic marketing.

In order to ensure continuous quality in the field,

WaveLight has built a wide spread support

network for technical and non-technical issues.

Our customers are exclusively supported through

factory certified service technicians and clinical

trainers. And we can be reached through a direct

service hotline from anywhere in the world.

Partner with competence intechnology and service

· Represented in more than 70 countries

through factory certified partners

· WaveLight subsidiaries in Europe and

North America

Certified Support

Quality Management

WaveLight maintains a quality management

system according to the following standards

and directives:

The ALLEGRETTO WAVE is FDA approved

in the USA according to the following

documents:

EC Directive 93/42/EEC on Medical Devices, Annex | |

CAN/CSA-ISO 13485-98

DIN EN ISO 9001:2000

DIN EN ISO 13485:2003

21 CFR 820 (USA) - Hyperopia (PMA No. P030008)

21 CFR 820 (USA) - Myopia (PMA No. P020050)

WaveLight SUPPORT

� �

Join a community of experts

WaveLight users share a commitment to quality,

safety and excellence. Over the years, our customers

have grown into a community of experts who ex-

change their experience and thoughts.

The WaveLight Campus serves as a platform for

interaction and exchange for our customers and their

peers with regular events, meetings and courses.

Becoming a WaveLight user also means to be-

come part of the community and gaining access

to a world of information and expertise.

Interaction and Exchange

WaveLight SUPPORT

Didactics:

clinical training, practice

development and practice

management

Campus is subdivided into four areas:

WaveLight Ambassadors:

a selected group of peers who

excel in education and research

and who serve as mentors,

preceptors and luminaries

WaveLightCommunity

Member

Events:

educational seminars and

annual user meetings

Campus Online:

secured internet area providing

information, materials and down-

loads and an exchange forum

� �

ALLEGRO Analyzer

Pre-Op (raw data)

Pre-Op

Ablation profile

An excellent device for customized refractive vision

correction, the ALLEGRO Analyzer is perfectly

aligned with the WaveLight laser systems.

The ALLEGRO Analyzer works in the visible spec-

trum according to the Tscherning principle: on

the basis of the same principle as the human eye.

As the first company to introduce wavefront

technology, WaveLight is the only company to

apply the Tscherning principle in its diagnostic

devices, because it prevents false positive results,

enhances the accuracy of readings and thus

minimizes the risk of false treatments.

Especially designed to deliver wavefront data

needed to perform wavefront-guided laser vision

correction, all components of the ALLEGRO

Analyzer, such as software, resolution and

algorithms have been optimized for WaveLight’s

laser systems.

Wavefront Technology

· Tscherning principle

· No false positive results

· Accurate autorefractor

· Integrated accomodation

· Automated centration

· Wavefront-guided treatments in conjunction

with the with the WaveLight laser systems

WaveLight DIAGNOSIS

� �

ALLEGRO Topolyzer

The ALLEGRO Topolyzer was designed to measure

and generate high-resolution treatment data of

the corneal surface.

With an extraordinarily high resolution of the cor-

nea, achieved by 22,000 measuring points, the

ALLEGRO Topolyzer is a high-precision tool for

customized refractive surgery.

The ALLEGRO Topolyzer works in perfect synchro-

nization with the WaveLight laser systems. Its

integrated keratometer and automatic measuring

release allow for precise image centration with

a peripheral standard deviation of only 4 micro-

meters.

Combined with the WaveLight laser systems, the

ALLEGRO Topolyzer enables the surgeon to

perform a precise topography-guided correction

of advanced clinical indications.

Corneal Topography

Pre-Op

Post-Op

Ablation profile

· High precision measurement with

22,000 measurement points

· Provides asphericity data

· Integrated keratometer

· Automatic measurement release

· Topography-guided treatments in conjunction

with the WaveLight laser systems

WaveLight DIAGNOSIS

� �

3D Wavefront

Customization does not start with the treatment,

it begins with the customized outfitting of your

surgery practice.

That is why WaveLight offers a range of diagnostic

and laser technology that can be exactly tailored to

your requirements.

Whether you are a high-volume clinic with the

goal to optimize patient flow, or an individual

specialist wanting the capability to treat complex

clinical indications: WaveLight provides the right

technology and support to achieve the best-

possible results.

The WaveLight customization toolkit comprises

several different customization tools that can be

combined with our laser systems and diagnostic

devices to maximize your capabilities:

· Wavefront-optimized

· Wavefront-guided

· Topography-guided

· Custom Q for asphericity-guided treatments,

customized refraction and optical zone entries

Customize your practice!

Meet your Needs

3D Topography

Custom Q

Custom Treatment Ranges

0

+6-14 sphere

+6-6 cylinder

+6-12 sphere

+3-3

+6-14 sphere

+6-6 cylinder

+6-14 sphere

+6-6 cylinder

Wavefront-optimized

A-CAT (Wavefront-guided)

T-CAT (Topography-guided)

Custom Q

cylinder

WaveLight CUSTOMIZATION

� �

RONDO is the first mechanical microkeratome

developed by WaveLight. With more predictability,

safety and precision it meets our high quality

standards and further completes the refractive

surgery process.

The unique design of the RONDO minimizes the

risk of flap complications. With an elevated suction

ring it will even work in very narrow eyes. The

ultrathin performance blades of the RONDO are

inserted with a special blade shooter, and create

predictably thin flaps and very smooth cuts. Its

integrated quality assurance – using barcode

scanning and data storage – provides physicians

with more control and patients with a higher level

of safety.

And lastly, RONDO comes with an integrated

thermal printer so that you can keep the surgery

records with your files.

RONDO

The Cutting Edge

RONDO features at a glance:

· Elevated suction ring with active vacuum adjustment

· Integrated peristaltic pump to connect aspiration lid retractor

· Oscillation: 8,000 rpm

· Automatic head advancement

· Variable hinge position and size

· Pre-assembled head for quick application onto the eye

· Flap thickness: 100, 130 and 150 m

· Flaps with very large diameter possible (8.0, 8.5, 9.0, 9.5, 10.0 mm)

· Low intraocular pressure ( 100mm Hg)

· Integrated barcode scanner and thermal printerWaveLight TREATMENT

� �

ALLEGRETTO WAVE™

The ALLEGRETTO WAVE is the gold standard in

refractive surgery. With a speed of 200 Hz, it uses

PerfectPulse Technology for intelligent laser pulse

control providing safety and accuracy in combina-

tion with outstanding visual results. It is the first

European laser to receive approval by the US Food

and Drug Administration FDA.

Having performed the first global wavefront-

guided treatment in 1999, the ALLEGRETTO WAVE

today is the most successfully sold WaveLight laser

system in the market with more than 400 instal-

lations around the world.

· 200 Hz ablation rate

· 0.95 mm (0.68 mm FWHM)

Gaussian laser beam

· 200 Hz active eyetracker

· PerfectPulse Technology

Developed to provide accuracy and safety at high

speed for WaveLight systems, PerfectPulse Technology

combines several state-of-the-art technologies to

control every single laser pulse from start to finish:

· Smart Energy Control

· Thermally optimized ablation pattern

· Automated fast track eyetracking

· Systematic peripheral pulse placement

Right. From the Start.

WaveLight TREATMENT

� �

The ALLEGRETTO WAVE Eye-Q takes the proven

ALLEGRETTO WAVE technology one step further.

With its additional customization capabilities it is

geared towards the advanced refractive surgeon

who seeks to further improve the surgery process.

A 400 Hz ablation rate makes the Eye-Q one

of the fastest lasers in the world and its unique

PerfectPulse Technology ensures safety and

accuracy in combination with outstanding visual

results.

The Eye-Q’s cross line projector enables the control

of head movement and improves precision.

Aside from the ability to perform wavefront-

optimized, wavefront-guided or topography-

guided treatments, the Eye-Q features Custom Q,

ALLEGRETTO WAVE Eye-Q

the first treatment module that allows the custo-

mization of corneal asphericity. Aside from tailor-

ing the corneal curvature, Custom Q also permits

the fine tuning of optical zones to 1/10 mm and

refraction to 1/100 diopter in order to maximize

treatment potential.

As an alternative to other customization methods,

Custom Q creates very large, functional optical

zones with minimized transition zones.

With the goal to provide the best suitable out-

comes to your patients, Custom Q adds a fourth

dimension to your treatment portfolio.

· 400 Hz ablation rate

· 0.95 mm (0.68 mm FWHM)

Gaussian laser beam

· 400 Hz active eyetracker

· PerfectPulse Technology

· Cross line projector

· Custom Q treatment module

WaveLight TREATMENT

One Step Further

� �

As the flagship of the WaveLight laser family,

the Concerto system is the first laser that fully

integrates diagnostic and treatment capabilities

into one laser platform.

As such, the Concerto is more than a demonstra-

tion of what is possible in refractive technology

today. For the first time ever, it meets the demands

for complete quality control.

The name Concerto was not chosen randomly

because it describes the perfect harmony and

interactivity of the elements safety, perfection,

quality, and individuality.

With the Concerto, the user can achieve the

excellent results of already existing WaveLight

lasers while going one step further.

The exclusiveness of the ALLEGRETTO WAVE

Concerto is defined by several factors:

· Innovative technical components

· A progressive design and the use of only

highest-quality materials

· Excellent operability and a comprehensive

package of technical and non-technical services

· Personalized, individual and direct support by

WaveLight

ALLEGRETTO WAVE Concerto

· 500 Hz ablation rate

· 0.95 mm (0.68 mm FWHM)

Gaussian laser beam

· 500 Hz active eyetracker

· Cross line projector

· SmartView Microscope

· No-touch pachymetry

· Online spectrometry

· Advanced PerfectPulse Technology

with Single Pulse Registration

· Custom Q, topography- and wavefront-

guided treatment modules

· Comes with diagnostic devices for

wavefront and topography measurements

and with the RONDO microkeratome

· Custom design in several different color schemes

WaveLight TREATMENT

Perfection in Detail

� �

Specifications are subject to change!

Working principle Tscherning Principle

Resolution 13 x 13 dots

(168 as the central point

is not measured)

Measurable pupil 3 to 8 mm

diameter

Measurement range -12 to +6 D sphere

-6 to +6 D astigmatism

Centration Eyetracking function

(centered on the gravity

center of the pupil)

Accuracy of the refrac- +/- 0.01 D

tion measurement

Repeatability +/- 0.05 D in consecutive

measurements

Accuracy of the Zernike polynomials up

wavefront measurement to the 6th order

Acquisition time app. 250 ms

Dimensions (L x W x H) 45 x21x 50 cm (optical unit)

Weight 15 kg (optical unit)

Repetition rate (Hz)

Treatment time Optical zone: 6.5 mm

Eyetracker (Hz)

Treatment range sphere (D)

cylinder (D)

Optical zone (mm)

Applications PTK ablation depth:

5-100 m, OZ 2-8 mm

Standard „wavefront-

optimized” refractive

treatment

Custom Q treatment

A-CAT treatment

in conjunction with the

ALLEGRO Analyzer

T-CAT treatment

in conjunction with the

ALLEGRO Topolyzer

Notebook

Online Measurement of

pachymetry cornea thickness

before and after

flap cutting

Spectrometer Measurement of

liquid on the

cornea surface

Slit lamp

Plume evacuation

Working distance (cm)

Single pulse

registration

Cross line Patient alignment

projector

N2 connection Internal / external

Dimensions (L x W x H)

Weight

ALLEGRETTO WAVE

200

4 s/D

200

- 14 to + 6

- 6 to + 6

Myopia: 4.5 - 8, in 0.5 mm steps,

without 7.5;

Hyperopia: 6 - 7 in 0.5 mm steps

x

x

Optional

Optional

Optional

x

-

-

Optional

External

20

-

-

x

120 x 145 x 130 cm

320 kg (incl. bed)

400

2.5 s/D

400

- 14 to + 6

- 6 to + 6

Myopia: 4.5 - 8, in 0.5 mm steps,

without 7.5;

Hyperopia: 6 - 7 in 0.5 mm steps

x

x

x

Optional

Optional

x

-

-

Optional

External

20

-

x

x

120 x 145 x 130 cm

320 kg (incl. bed)

ALLEGRETTO WAVE Eye-Q ALLEGRETTO WAVE Concerto

500

2 s/D

500

- 14 to + 6

- 6 to + 6

Myopia: 4.5 - 8, in 0.5 mm steps,

without 7.5;

Hyperopia: 6 - 7 in 0.5 mm steps

x

x

x

x

x

Internal PC

x

x

x

Integrated

29

x

x

Integrated

170 x 120 x 125 cm

400 kg (incl. bed, excl. gas)

ALLEGRO Analyzer ALLEGRO Topolyzer

Measuring range 3 to 38 mm

(corneal radius)

9 to 99 D

(refractive power)

Accuracy 0.1 D

Reproduceability 0.1 D

Number of rings 11

Working distance 80 mm

Data points evaluated 22,000

Dimensions (D x W x H) 17 x 26 x 42 cm

Weight (measuring head) 2.3 kg

Suction ring diameter 19.0 mm

Flap diameter 8.0 mm

8.5 mm

9.0 mm

9.5 mm

10.0 mm

variable hinge:

min. 4.0 mm

Cutting head Flap thickness:

100 m

130 m

150 m

Oscillation 8,000 rpm

Vacuum 400 - 600 mmHg

User interface Touch screen

Dimensions (LxWxH) 37 x 50 x 25 cm

Weight 20 kg

RONDO

Technical Data & References

Specifications at a GlanceFor detailed technical data and references ask for

the WaveLight product brochures.

CAUTION: The products mentioned in this brochure are not available for sale in the US!