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 |