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510(k) K023249

Device
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
Applicant
ALCON LABORATORIES, INC.
510(k) number
K023249
Product code
NCF  
Decision
Substantially Equivalent (SESE)
Decision date
2002-10-18
Date received
2002-09-30
Regulation
886.1760
Classification name
Aberrometer, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHRISTY STEVENS
Address
2501 Discovery Dr., Suite 500 Orlando FL US 32826 32826

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NCF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K062930LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEMAlcon Research, Ltd.2006-11-08
K050336OPD-STATION SOFTWARENidek, Inc.2005-08-24
K000637CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)Alcon Laboratories, Inc.2000-05-19

Legacy Summary#

summary

FDA Review#

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