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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K200736
Device Name Stardust Med
Applicant
I.T.S. Group S.R.L.
Via Del Cerchio, 1
Calderara Di Reno,  IT 40012
Applicant Contact Claudio Bellina
Correspondent
Endo Engineering S.R.L.
Via Del Consorzio, 41
Falconara Marittima,  IT 60015
Correspondent Contact Chiara Violini
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/23/2020
Decision Date 06/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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