PMA P990027S002

Device

TECHNOLAS 217A EXCIMER LASER SYSTEM

Applicant

Technolas Perfect Vision GmbH

PMA number

P990027

Supplement

S002

Product code

LZS

Decision date

2002-05-17

Classification

Excimer Laser System

Generic name

Excimer laser system

Approval order statement

APPROVAL THE TECHNOLAS 217A EXCIMER LASER SYSTEM. THIS DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIC ASTIGMATISM UP TO -12.00 D MRSE, WITH SPHERE BETWEEN >-7.00 D TO -10.99 D AND CYLINDER BETWEEN 0.00 AND <-3.00 D; 2) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.50 DIOPTERS (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF THE PRE-OPERATIVE EXAMINATION; AND, 3) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P990027S002B.pdf" target="_new">Summary of Safety and Effectiveness</a>