LUMENIS SELECTA DUET

Powered Laser Surgical Instrument

Ellex Medical Pty. Ltd.

The following data is part of a premarket notification filed by Ellex Medical Pty. Ltd. with the FDA for Lumenis Selecta Duet.

Pre-market Notification Details

Device IDK021550
510k NumberK021550
Device Name:LUMENIS SELECTA DUET
ClassificationPowered Laser Surgical Instrument
Applicant Ellex Medical Pty. Ltd. 7138 SHADY OAK RD. Minneapolis,  MN  55344
ContactBill Swaim
CorrespondentBill Swaim
Ellex Medical Pty. Ltd. 7138 SHADY OAK RD. Minneapolis,  MN  55344
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-13
Decision Date2002-08-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09342395000649 K021550 000
09342395000588 K021550 000

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