WAVELIGHT FS200 PATIENT INTERFACE 1505

Powered Laser Surgical Instrument

ALCON RESEARCH, LTD.

The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Wavelight Fs200 Patient Interface 1505.

Pre-market Notification Details

Device IDK121031
510k NumberK121031
Device Name:WAVELIGHT FS200 PATIENT INTERFACE 1505
ClassificationPowered Laser Surgical Instrument
Applicant ALCON RESEARCH, LTD. 6201 SOUTH FREEWAY Fort Worth,  TX  76134 -2099
ContactMichael Buenger
CorrespondentMichael Buenger
ALCON RESEARCH, LTD. 6201 SOUTH FREEWAY Fort Worth,  TX  76134 -2099
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-05
Decision Date2012-06-21
Summary:summary

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