PMA P980008S005
- Device
- LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)
- Applicant
- Lasersight Technologies, Inc.
- PMA number
- P980008
- Supplement
- S005
- Product code
- LZS
- Decision date
- 2001-09-28
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR THE LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK). THE DEVICE IS INDICATED FOR LASIK: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM -0.5 TO LESS THAN -6.0 DIOPTERS (D) SPHERICAL EQUIVALENT, WITH ASTIGMATISM LESS THAN OR EQUAL TO 4.5 D, AS MEASURED AT THE SPECTACLE PLANE; 2) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D, OR <= 10% OF PREOPERATIVE SPHERICAL EQUIVALENT REFRACTION (SER) SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND, 3) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P980008S005B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)
- Applicant
- Lasersight Technologies, Inc.
- PMA number
- P980008
- Supplement
- S005
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2001-09-28
- Decision code
- APPR
- Date received
- 2000-12-19
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK). THE DEVICE IS INDICATED FOR LASIK: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM -0.5 TO LESS THAN -6.0 DIOPTERS (D) SPHERICAL EQUIVALENT, WITH ASTIGMATISM LESS THAN OR EQUAL TO 4.5 D, AS MEASURED AT THE SPECTACLE PLANE; 2) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS