The following data is part of a premarket notification filed by Ceramoptec Gmbh with the FDA for Leonardo Mini Blue.
Device ID | K210951 |
510k Number | K210951 |
Device Name: | Leonardo Mini Blue |
Classification | Powered Laser Surgical Instrument |
Applicant | CeramOptec GmbH Siemensstrabe 44 Bonn, DE D-53121 |
Contact | Roland Dreschau |
Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-03-30 |
Decision Date | 2021-09-01 |