PMA P930016S048
- Device
- STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S048
- Product code
- LZS
- Decision date
- 2017-06-30
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- Approval for the STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System. The STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System is indicated for Wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: 1) with hyperopia with and without astigmatism as measured by iDesign® Advanced WaveScan Studio System up to +4.00 D spherical equivalent, with up to 2.00 D cylinder;2) with agreement between manifest refraction (adjusted for optical infinity) and iDesign® Advanced WaveScan Studio System refraction as follows: - Spherical Equivalent: Magnitude of the difference is less than 0.625 D. - Cylinder: Magnitude of the difference is less than or equal to 0.5 D;3) 18 years of age or older; and4) with refractive stability (a change of less than or equal to 1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery).
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P930016S048B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S048
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2017-06-30
- Decision code
- APPR
- Date received
- 2016-12-01
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System. The STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System is indicated for Wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: 1) with hyperopia with and without astigmatism as measured by iDesign® Advanced WaveScan Studio System up to +4.00 D spherical equivalent, with up to 2.00 D cylinder;2) with agreement between manifest refraction (adjusted for optical infinity) and iDesign® Advanced WaveScan Studio System refraction as follows: - Spherical Equivalent: Magnitude of the difference is less than 0.625 D. - Cylinder: Magnitude of the difference is less than or equal to 0.5 D;3) 18 years of age or older; and4) with refractive stability (a change of less than or equal to 1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery).