VISX EXCIMER LASER SYSTEM MODELS B AND C
FDA premarket approval P930016/S003 · decided 1997-04-24
Approval details
- PMA number
- P930016
- Supplement
- S003
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VISX EXCIMER LASER SYSTEM MODELS B AND C
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 1996-08-26
- Decision date
- 1997-04-24
- Days to decision
- 241 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- Yes
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR THE VISX EXCIMER LASER SYSTEM (MODELS B & C). THIS DEVICE IS INDICATED FOR MYOPIC ASTIGMATIC PHOTOREFRACTIVE KERATECTOMY (PRKA) USING AN ABLATION ZONE WITH A 6.0 MM MAJOR AXIS
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510(k) clearances by this applicant
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