Atlas FDA

SVS APEX PLUS EXIMER LASER SYSTEM

FDA premarket approval P930034/S002 · decided 1997-02-07

Approval details

PMA number
P930034
Supplement
S002
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
SVS APEX PLUS EXIMER LASER SYSTEM
Generic name
Excimer laser system
Applicant
Alcon Laboratories, Inc.
Date received
1996-01-29
Decision date
1997-02-07
Days to decision
375 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 SYSTEM.

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510(k) clearances by this applicant

RecordFirmDate
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UNITY VCS (8065000296); UNITY CS (8065000297) (K233876)Alcon Laboratories, Inc.2024-06-21
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Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856)Alcon Laboratories, Inc.2023-12-29