GEMINI OPHTHALMIC SURGERY SYSTEM

Unit, Phacofragmentation

ALCON LABORATORIES

The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Gemini Ophthalmic Surgery System.

Pre-market Notification Details

Device IDK911808
510k NumberK911808
Device Name:GEMINI OPHTHALMIC SURGERY SYSTEM
ClassificationUnit, Phacofragmentation
Applicant ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth,  TX  76134 -2099
ContactDavid Krapf
CorrespondentDavid Krapf
ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth,  TX  76134 -2099
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-23
Decision Date1991-06-25

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