VISX STAR S2 AND S3 EXCIMER LASER SYSTEM
FDA premarket approval P930016/S010 · decided 2000-10-18
Approval details
- PMA number
- P930016
- Supplement
- S010
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VISX STAR S2 AND S3 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 1999-06-18
- Decision date
- 2000-10-18
- Days to decision
- 488 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- Yes
- Location
- Milpitas, CA
- Statement
- THESE DEVICES ARE INDICATED FOR PHOTOREFRACTIVE KERATECTOMY (PRK) TREATMENTS: IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.5 D PER YEAR FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; ANDIN PATIENTS 21 YEARS OF AGE OR OLDER FOR THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING HYPEROPIA BETWEEN +0.5 AND + 5.0 D SPHERE AT THE SPECTACLE PLANE WITH REFRACTIVE ASTIGMATISM FROM +0.5 TO +4.0 D WITH A MAXIMUM MANIFEST REFRACT
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