Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo

Laser, Ophthalmic

Ellex Medical Pty Ltd

The following data is part of a premarket notification filed by Ellex Medical Pty Ltd with the FDA for Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo.

Pre-market Notification Details

Device IDK222395
510k NumberK222395
Device Name:Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
ClassificationLaser, Ophthalmic
Applicant Ellex Medical Pty Ltd 3-4 Second Avenue Mawson Lakes Adelaide,  AU
ContactRashmi Pillay
CorrespondentMaureen O`Connell
O`Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham,  MA  02180
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-08
Decision Date2022-11-02

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