Leonardo Mini Blue

Powered Laser Surgical Instrument

CeramOptec GmbH

The following data is part of a premarket notification filed by Ceramoptec Gmbh with the FDA for Leonardo Mini Blue.

Pre-market Notification Details

Device IDK210951
510k NumberK210951
Device Name:Leonardo Mini Blue
ClassificationPowered Laser Surgical Instrument
Applicant CeramOptec GmbH Siemensstrabe 44 Bonn,  DE D-53121
ContactRoland Dreschau
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-30
Decision Date2021-09-01

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