LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM

Aberrometer, Ophthalmic

ALCON RESEARCH, LTD.

The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Ladarwave Customcornea Wavefront System.

Pre-market Notification Details

Device IDK062930
510k NumberK062930
Device Name:LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
ClassificationAberrometer, Ophthalmic
Applicant ALCON RESEARCH, LTD. 2501 DISCOVERY DR. SUITE 500 Orlando,  FL  32826
ContactJanet G Johnson
CorrespondentJanet G Johnson
ALCON RESEARCH, LTD. 2501 DISCOVERY DR. SUITE 500 Orlando,  FL  32826
Product CodeNCF  
CFR Regulation Number886.1760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-28
Decision Date2006-11-08
Summary:summary

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