Atlas FDA

SVS APEX PLUS EXCIMER LASER WORKSTATION

FDA premarket approval P930034/S011 · decided 1998-06-04

Approval details

PMA number
P930034
Supplement
S011
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
SVS APEX PLUS EXCIMER LASER WORKSTATION
Generic name
Excimer laser system
Applicant
Alcon Laboratories, Inc.
Date received
1998-05-21
Decision date
1998-06-04
Days to decision
14 days
Decision code
APPR
Product code
LZS
Advisory committee
Ophthalmic
Expedited review
No
Location
Orlando, FL
Statement
Approval for an external chiller option for the SVS Apex Plus Excimer Lasery System.

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510(k) clearances by this applicant

RecordFirmDate
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Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856)Alcon Laboratories, Inc.2023-12-29