PMA P930016S017
- Device
- STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S017
- Product code
- LZS
- Decision date
- 2004-12-14
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR THE STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USES A 6.00 MM OPTICAL ZONE, A 9.00 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA AN D HYPEROPIC ASTIGMATISM UP TO 3.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND 2.00 D; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 1.0 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P930016S017B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S017
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2004-12-14
- Decision code
- APPR
- Date received
- 2003-11-28
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USES A 6.00 MM OPTICAL ZONE, A 9.00 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA AN D HYPEROPIC ASTIGMATISM UP TO 3.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND 2.00 D; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 1.0 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION.