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LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM

FDA premarket approval P970043/S022 · decided 2006-05-02

Approval details

PMA number
P970043
Supplement
S022
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM
Generic name
Excimer laser system
Applicant
Alcon Laboratories
Date received
2005-11-03
Decision date
2006-05-02
Days to decision
180 days
Decision code
APPR
Product code
LZS
Advisory committee
Ophthalmic
Expedited review
No
Location
Fort Worth, TX
Statement
APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM. THESE DEVICES USE A 6.5 MM OPTICAL ZONE AND A 9.0 TREATMENT ZONE AND ARE INDICATED FOR WAVE-FRONT GUIDED CUSTOMCORNEA LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MIXED ASTIGMATISM 1.00 D TO LESS THAN 5.00 D CYCLOPLEGIC CYLINDER MAGNITUDE AT THE SPECTACLE PLANE, WHICH IS GREATER THAN THE SPHERE MAGNITUDE, AND THE CYLINDER AND SPHERE HAVE OPPOSITE SIGNS; 2) IN P

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510(k) clearances by this applicant

RecordFirmDate
NEXT GENERATION LASER (K062624)Alcon Laboratories2007-11-05
SMALL VOLUME SYRINGE (K062865)Alcon Laboratories2007-08-23
RGP MULTI-PURPOSE SOLUTION ID 100136 (K000148)Alcon Laboratories2000-04-11
OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP (K984573)Alcon Laboratories1999-09-16
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER (K990480)Alcon Laboratories1999-05-10
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K984575)Alcon Laboratories1999-01-14
OPTI-ONE MULTI-PURPOSE SOLUTION (K983973)Alcon Laboratories1998-12-18
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K983780)Alcon Laboratories1998-12-18