510(k) K062930

Device: LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
Applicant: ALCON RESEARCH, LTD.
510(k) number: K062930
Product code: NCF
Decision: Substantially Equivalent (SESE)
Decision date: 2006-11-08
Date received: 2006-09-28
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: JANET G JOHNSON
Address: 2501 Discovery Dr., Suite 500 Orlando FL US 32826 32826

FDA Registration Numbers#

3019255798
2028159
1920664
3007606649
1651254
3010208880
3011422483
3003288808
1313525
9710340
3011977270

Source Documents#

Other 510(k) Records For Product Code NCF #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K050336	OPD-STATION SOFTWARE	Nidek, Inc.	2005-08-24
K023249	ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM	Alcon Laboratories, Inc.	2002-10-18
K000637	CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)	Alcon Laboratories, Inc.	2000-05-19

Legacy Summary#

summary

FDA Review#

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