SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS DISC
FDA premarket approval P930034/S009 · decided 1998-03-11
Approval details
- PMA number
- P930034
- Supplement
- S009
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS DISC
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1997-04-02
- Decision date
- 1998-03-11
- Days to decision
- 343 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Orlando, FL
- Statement
- Approval for the SVS Apex Plus Excimer Laser Workstation and emphasis(R) disc. These devices are indicated to perform myopic astigmatic photorefractive keratectomy (Toric PRK): 1) for the reduction or elimination of mild to moderate myopia (-1.00 to < -6.00 D) and concomitant reduction or elimination of mild to moderate astigmatism (-1.00 to < -4.00D), in which the combined attempted correction must be < -6.00D spherical equivalent at the spectacle plane; 2) in patients with documentation of a s
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510(k) clearances by this applicant
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