PMA P060004S001
- Device
- MEDITEC MEL 80 EXCIMER LASER SYSTEM
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P060004
- Supplement
- S001
- Product code
- LZS
- Decision date
- 2011-03-28
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR THE MEL 80 EXCIMER LASER SYSTEM. THIS DEVICE USES AN OPTICAL ZONE OF 6.0 TO 6.5 MM IN DIAMETER AND A TRANSITION ZONE OF 2.0 TO 4.0 MM FOR A TOTAL ABLATION DIAMETER OF 10.0 MM, AND IS INDICATED FOR PRIMARY LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR: 1) THE REDUCTION OR ELIMINATION OF NATURALLY-OCCURRING HYPEROPIA OF LESS THAN OR EQUAL TO +5.0 D WITH OR WITHOUT REFRACTIVE ASTIGMATISM OF > +0.5 AND <= +3.0D, WITH A MAXIMUM MRSE OF +5.0D; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND 3) WITH DOCUMENTATION OF STABLE MANIFEST REFRACTION OVER THE PAST YEAR AS DEMONSTRATED BY CHANGE IN SPHERE AND CYLINDER OF <= 0.5D.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060004S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- MEDITEC MEL 80 EXCIMER LASER SYSTEM
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P060004
- Supplement
- S001
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2011-03-28
- Decision code
- APPR
- Date received
- 2007-12-28
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MEL 80 EXCIMER LASER SYSTEM. THIS DEVICE USES AN OPTICAL ZONE OF 6.0 TO 6.5 MM IN DIAMETER AND A TRANSITION ZONE OF 2.0 TO 4.0 MM FOR A TOTAL ABLATION DIAMETER OF 10.0 MM, AND IS INDICATED FOR PRIMARY LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR: 1) THE REDUCTION OR ELIMINATION OF NATURALLY-OCCURRING HYPEROPIA OF LESS THAN OR EQUAL TO +5.0 D WITH OR WITHOUT REFRACTIVE ASTIGMATISM OF > +0.5 AND