SVS APEX EXCIMER LASER SYSTEM
FDA premarket approval P930034 · decided 1995-10-20
Approval details
- PMA number
- P930034
- Trade name
- SVS APEX EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1993-10-12
- Decision date
- 1995-10-20
- Days to decision
- 738 days
- Decision code
- APWD
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Orlando, FL
- Statement
- INDICATED FOR A 6.0 MM ABLATION ZONE, MYOPIC PHOTOREFRACTIVE KERATECTOMY (PRK) IN PATIENTS WHO MEET ALL OF THE FOLLOWING CRITERIA:1)1.5 TO 7.0 DIOPTERS OF MYOPIA WITH ASTIGMATISM OF <- 1.5 DIOPTERS; 2)REFRACTION IS WITHIN +- 1.0 DIOPTER FOR ONE YEAR PRIOR TOT HE LASER TREATMENT; AND 3) 21 YEARS OF AGE OR OLDER
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510(k) clearances by this applicant
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