Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo

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, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo.

Pre-market Notification Details

Device IDK212630
510k NumberK212630
Device Name:Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
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 Received2021-08-19
Decision Date2021-12-16

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