Data / Medical devices / Powered Laser Surgical Instrument / Germany
FDA-registered makers of Powered Laser Surgical Instrument in Germany: 24 establishments
24 establishments in Germany are registered with the FDA to make Powered Laser Surgical Instrument (product code GEX). 18 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Powered Laser Surgical Instrument
- Product code
- GEX
- Country
- Germany
Makers of Powered Laser Surgical Instrument in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Asclepion Laser Technologies GmbH | Jena Thuringia, Germany | Exporter to the US, Manufacturer, Specification developer | 13 | April 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| Dornier Medtech GMBH | WESSLING Bavaria, Germany | Complaint file establishment, Manufacturer | 12 | July 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Lisa Laser Products GMBH | KATLENBURG-LINDAU Lower Saxony, Germany | Manufacturer | 9 | May 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Carl Zeiss Meditec AG (jena) | JENA Thuringia, Germany | Specification developer | 8 | March 17, 2010 | 0 | 0 | 0 | api.fda.gov |
| Carl Zeiss Meditec AG (Jena) | Jena Thuringia, Germany | Manufacturer | 8 | March 17, 2010 | 0 | 0 | 0 | api.fda.gov |
| Ceramoptec GMBH | Bonn North Rhine-Westphalia, Germany | Manufacturer | 5 | July 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| German Medical Engineering GMBH | Erlangen Bavaria, Germany | Manufacturer | 5 | March 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 4 | September 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| A.R.C. Laser GMBH | Bavaria, Germany | Manufacturer | 3 | September 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sirona Dental Systems GMBH | BENSHEIM Hesse, Germany | Manufacturer, Specification developer | 3 | March 8, 2018 | 0 | 0 | 0 | api.fda.gov |
| Zimmer Medizinsysteme GMBH | NEU-ULM Bavaria, Germany | Contract manufacturer, Exporter to the US, Manufacturer | 3 | February 4, 2022 | 0 | 0 | 0 | api.fda.gov |
| Heager GmbH | HAAN North Rhine-Westphalia, Germany | Manufacturer, Repackager or relabeler, Specification developer | 1 | August 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Repackager or relabeler | 1 | January 23, 2006 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer, Repackager or relabeler | 1 | January 23, 2006 | 0 | 0 | 0 | api.fda.gov |
| Oberon GMBH Fiber Technologies | Wildau Brandenburg, Germany | Manufacturer | 1 | October 15, 2014 | 0 | 0 | 0 | api.fda.gov |
| Od-Os GMBH | Teltow Brandenburg, Germany | Manufacturer | 1 | November 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| WAVELIGHT GmbH | ERLANGEN Bavaria, Germany | Specification developer | 1 | March 26, 2019 | 0 | 0 | 0 | api.fda.gov |
| WAVELIGHT GmbH | PRESSATH Bavaria, Germany | Manufacturer | 1 | March 26, 2019 | 0 | 0 | 0 | api.fda.gov |
| Advanced Fiber Tools GMBH | Mittweida Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HGR Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jr-Medizintechnik GMBH & Co KG | Leibertingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifephotonic GMBH | BONN North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vomed Volzer Medizintechnik GMBH & Co.kg | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.