PMA P990027S004
- Device
- TECHNOLAS 217A EXCIMER LASER SYSTEM
- Applicant
- Technolas Perfect Vision GmbH
- PMA number
- P990027
- Supplement
- S004
- Product code
- LZS
- Decision date
- 2003-02-25
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR THE TECHNOLAS 217A EXCIMER LASER SYSTEM. THE DEVICE USES AN OPTICAL ZONE TREATMENT RANGE FROM 5.00 MM TO 6.00 MM WITH A BLEND ZONE OF 1.90 MM FOR SPHERICAL HYPEROPIA AND 1.75 MM FOR HYPEROPIC ASTIGMATISM. THE LASER IS LOCKED OUT FOR REFRACTIVE CORRECTIONS GREATER THAN +4.00 D SPHERE AND GREATER THAN +2.00 D CYLINDER. THE DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATION OF LOW-TO-MODERATE NATURALLY OCCURRING HYPEROPIA UP TO +4.00 DIOPTERS (D) MRSE, WITH SPHERE BETWEEN +1.00 TO +4,00 D WITH OR WITHOUT REFRACTIVE ASTIGMATISM UP TO +2.00 D AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND, 3) 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P990027S004B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- TECHNOLAS 217A EXCIMER LASER SYSTEM
- Applicant
- Technolas Perfect Vision GmbH
- PMA number
- P990027
- Supplement
- S004
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2003-02-25
- Decision code
- APPR
- Date received
- 2001-12-14
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE TECHNOLAS 217A EXCIMER LASER SYSTEM. THE DEVICE USES AN OPTICAL ZONE TREATMENT RANGE FROM 5.00 MM TO 6.00 MM WITH A BLEND ZONE OF 1.90 MM FOR SPHERICAL HYPEROPIA AND 1.75 MM FOR HYPEROPIC ASTIGMATISM. THE LASER IS LOCKED OUT FOR REFRACTIVE CORRECTIONS GREATER THAN +4.00 D SPHERE AND GREATER THAN +2.00 D CYLINDER. THE DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATION OF LOW-TO-MODERATE NATURALLY OCCURRING HYPEROPIA UP TO +4.00 DIOPTERS (D) MRSE, WITH SPHERE BETWEEN +1.00 TO +4,00 D WITH OR WITHOUT REFRACTIVE ASTIGMATISM UP TO +2.00 D AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND, 3) 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.