PMA P930016S020
- Device
- STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S020
- Product code
- LZS
- Decision date
- 2005-03-17
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR THE VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VSS AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USES A 6.0 MM OPTICAL ZONE, A 9.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR EE AND THE CYLINDER AND SPHERE HAVE OPPOSITE SIGNS; 2) IN PATIENTS 21 YEARS OF ATH 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/P930016S020B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S020
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2005-03-17
- Decision code
- APPR
- Date received
- 2004-09-21
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VSS AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USES A 6.0 MM OPTICAL ZONE, A 9.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR EE AND THE CYLINDER AND SPHERE HAVE OPPOSITE SIGNS; 2) IN PATIENTS 21 YEARS OF ATH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION.