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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Asclepion Laser Technologies GmbHJena Thuringia, GermanyExporter to the US, Manufacturer, Specification developer13April 29, 2026000api.fda.gov
Dornier Medtech GMBHWESSLING Bavaria, GermanyComplaint file establishment, Manufacturer12July 27, 2022000api.fda.gov
Lisa Laser Products GMBHKATLENBURG-LINDAU Lower Saxony, GermanyManufacturer9May 19, 2022000api.fda.gov
Carl Zeiss Meditec AG (jena)JENA Thuringia, GermanySpecification developer8March 17, 2010000api.fda.gov
Carl Zeiss Meditec AG (Jena)Jena Thuringia, GermanyManufacturer8March 17, 2010000api.fda.gov
Ceramoptec GMBHBonn North Rhine-Westphalia, GermanyManufacturer5July 14, 2025000api.fda.gov
German Medical Engineering GMBHErlangen Bavaria, GermanyManufacturer5March 10, 2023000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer4September 8, 2023000api.fda.gov
A.R.C. Laser GMBHBavaria, GermanyManufacturer3September 1, 2022000api.fda.gov
Sirona Dental Systems GMBHBENSHEIM Hesse, GermanyManufacturer, Specification developer3March 8, 2018000api.fda.gov
Zimmer Medizinsysteme GMBHNEU-ULM Bavaria, GermanyContract manufacturer, Exporter to the US, Manufacturer3February 4, 2022000api.fda.gov
Heager GmbHHAAN North Rhine-Westphalia, GermanyManufacturer, Repackager or relabeler, Specification developer1August 26, 2025000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Repackager or relabeler1January 23, 2006000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer, Repackager or relabeler1January 23, 2006000api.fda.gov
Oberon GMBH Fiber TechnologiesWildau Brandenburg, GermanyManufacturer1October 15, 2014000api.fda.gov
Od-Os GMBHTeltow Brandenburg, GermanyManufacturer1November 22, 2016000api.fda.gov
WAVELIGHT GmbHERLANGEN Bavaria, GermanySpecification developer1March 26, 2019000api.fda.gov
WAVELIGHT GmbHPRESSATH Bavaria, GermanyManufacturer1March 26, 2019000api.fda.gov
Advanced Fiber Tools GMBHMittweida Saxony, GermanyContract manufacturer0000api.fda.gov
HGR Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jr-Medizintechnik GMBH & Co KGLeibertingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Lifephotonic GMBHBONN North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Vomed Volzer Medizintechnik GMBH & Co.kgTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.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.