Stardust Med

Powered Laser Surgical Instrument

I.T.S. Group S.R.L.

The following data is part of a premarket notification filed by I.t.s. Group S.r.l. with the FDA for Stardust Med.

Pre-market Notification Details

Device IDK200736
510k NumberK200736
Device Name:Stardust Med
ClassificationPowered Laser Surgical Instrument
Applicant I.T.S. Group S.R.L. Via Del Cerchio, 1 Calderara Di Reno,  IT 40012
ContactClaudio Bellina
CorrespondentChiara Violini
Endo Engineering SRL Via Del Consorzio, 41 Falconara Marittima,  IT 60015
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-23
Decision Date2020-06-26

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