PMA P990027S015

Device

TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION

Applicant

Technolas Perfect Vision GmbH

PMA number

P990027

Supplement

S015

Product code

LZS

Decision date

2010-11-30

Classification

Excimer Laser System

Generic name

Excimer laser system

Approval order statement

APPROVAL FOR THE ADVANCED NOMOGRAM SOFTWARE MODULE AS AN UPGRADE TO THE EXISTING SOFTWARE OF THE TECHNOLAS PERFECT VISION® 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION. THE ADVANCED NOMOGRAM RESIDES ON A SEPARATE COMPUTER WITH THE ZYLINK TREATMENTCALCULATION SOFTWARE, AND IT LEAVES ALL HARDWARE COMPONENTS AND THE LASER BEAM CONTROL SOFTWARE MODULE UNCHANGED. THE TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZEDVISION CORRECTION WITH ADVANCED NOMOGRAM SOFTWARE MODULE IS INDICATED FOR WAVEFRONT-GUIDEDLASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK):1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00 D AND CYLINDER UP TO-3.00 D AND MRSE <=7.50 D AT THE SPECTACLE PLANE;2) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OREQUAL TO +-0.50 DIOPTERS (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEARPRIOR TO THE DATE OF THE PRE-OPERATIVE EXAMINATION; AND3) IN PATIENTS 21 YEARS OF AGE OR OLDER.