Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM
- PMA Number
- P930016
- Supplement Number
- S025
- Device Class
- FDA Class 3
- Product Code
- LZS
- Generic Name
- Excimer laser system
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 11, 2007
- Date Received
- September 29, 2006
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 07M-0288
Advisory Committee Statement
APPROVAL FOR THE STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USED A 6.0 MM OPTICAL ZONE, AN 8.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TO ACHIEVE MONOVISION BY THE TARGETED RETENTION OF MYOPIA (-1.25 TO -2.00 D) IN THE NON-DOMINANT EYE OF PRESBYOPIC MYOPES: 1) 40 YEARS OR OLDER WHO MAY BENEFIT FROM INCREASED SPECTACLE INDEPENDENCE ACROSS A RANGE OF DISTANCES WITH USEFUL NEAR VISION; 2) WITH MYOPIC ASTIGMATISM UP TO -6.00 D MRSE, WITH CYLINDER UP TO -3.00 D, AND MINIMUM PRE-OPERATIVE MYOPIA IN THEIR NON-DOMINANT EYE AT LEAST AS GREAT AS THEIR TARGETED MYOPIA; 3) WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.50 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; AND 4) WITH A SUCCESSFUL PRE-OPERATIVE TRIAL OF MONOVISION OR HISTORY OF MONOVISION EXPERIENCE.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZS | Excimer Laser System | FDA class 3 | Unknown |