PMA P970053S009
- Device
- NIDEK EC-5000 EXCIMER LASER SYSTEM
- Applicant
- Nidek Co., Ltd.
- PMA number
- P970053
- Supplement
- S009
- Product code
- LZS
- Decision date
- 2006-10-11
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR THE NIDEK EC-5000 EXCIMER LASER SYSTEM. THE DEVICE USES A 6.0 MM OPTICAL ZONE AND A 9.0 MM TREATMENT ZONE AND IS INDICATED FOR LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA REFRACTIVE ERRORS FROM +0.5 TO +5.0 D OF SPHERE WITH OR WITHOUT ASTIGMATIC REFRACTIVE ERRORS FROM +0.5 TO +2.0 D AT THE SPECTACLE PLANE WITH MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +5.0 D OR LESS; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED STABILITY OF MANIFEST REFRACTION OVER THE PRIOR YEAR, DEMONSTRATED BY A CHANGE IN MRSE NOT GREATER THAN +/- 0.50 DIOPTER.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P970053S009B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- NIDEK EC-5000 EXCIMER LASER SYSTEM
- Applicant
- Nidek Co., Ltd.
- PMA number
- P970053
- Supplement
- S009
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2006-10-11
- Decision code
- APPR
- Date received
- 2005-11-23
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE NIDEK EC-5000 EXCIMER LASER SYSTEM. THE DEVICE USES A 6.0 MM OPTICAL ZONE AND A 9.0 MM TREATMENT ZONE AND IS INDICATED FOR LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA REFRACTIVE ERRORS FROM +0.5 TO +5.0 D OF SPHERE WITH OR WITHOUT ASTIGMATIC REFRACTIVE ERRORS FROM +0.5 TO +2.0 D AT THE SPECTACLE PLANE WITH MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +5.0 D OR LESS; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED STABILITY OF MANIFEST REFRACTION OVER THE PRIOR YEAR, DEMONSTRATED BY A CHANGE IN MRSE NOT GREATER THAN +/- 0.50 DIOPTER.