VISX STAR EXCIMER LASER SYSTEM
FDA premarket approval P930016/S012 · decided 2001-04-27
Approval details
- PMA number
- P930016
- Supplement
- S012
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VISX STAR EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2000-07-14
- Decision date
- 2001-04-27
- Days to decision
- 287 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- Yes
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR THE VISX STAR S2 AND S3 EXCIMER LASER SYSTEMS. THE DEVICES ARE INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.5 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; AND 2) IN PATIENTS 21 YEARS OF AGE OR OLDER IN TREATMENTS FOR THE REDUCTION OF ELIMINATION OF NATURALLY OCCURRING HYPEROPIA BETWEEN +05 AND +5.0 D SPHERE
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