Data / Medical devices / Germany / Ceramoptec GMBH
Ceramoptec GMBH: FDA-registered device maker in Bonn North Rhine-Westphalia, Germany, 5 510(k) clearances
Ceramoptec GMBH is registered with the FDA (registration 3003340844) in Bonn North Rhine-Westphalia, Germany. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated July 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003340844
- Address
- Siemensstrabe 44, Bonn North Rhine-Westphalia, Germany, D-53121
- Owner or operator
- CeramOptec GmbH (10075649)
- Roles
- Manufacturer
- First device listed
- June 29, 2020
- Registered through
- 2026
- Brand names listed
- Leonardo, Leonardo® Duster, Leonardo® Duster reusable Fibers, Leonardo® Duster single-use Fibers, PLDD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 14, 2025 | K250504 | Leonardo Duster | GEX | Substantially Equivalent | Ceramoptec GmbH | accessdata.fda.gov |
| September 1, 2021 | K210951 | Leonardo Mini Blue | GEX | Substantially Equivalent | Ceramoptec GmbH | accessdata.fda.gov |
| April 24, 2012 | K120231 | EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) | GEX | Substantially Equivalent | Biolitec Medical Devices, Inc. | accessdata.fda.gov |
| January 20, 2012 | K113709 | MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE | GEX | Substantially Equivalent | Biolitec Medical Devices, Inc. | accessdata.fda.gov |
| September 20, 2011 | K112253 | CERALAS 147NM DIODE LASER SYSTEM | GEX | Substantially Equivalent | Biolitec, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.