DORNIER MEDTECH GMBH

FDA Device Registration & Listing · WESSLING Bavaria, DE · Registration 9611388

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9611388
FEI Number
3002806833
Entity Name
DORNIER MEDTECH GMBH
City/State/Country
WESSLING Bavaria, DE
Establishment Address
ARGELSRIEDER FELD 7, WESSLING Bavaria D-82234, DE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
DORNIER MEDTECH GMBH (Owner Number: 8010622)
Owner / Operator Contact Address
ARGELSRIEDER FELD 7, --, WESSLING, DE-BY D82234, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K061455
PMA Number
N/A

All Registered Proprietary Names

Urotract OPUS Dornier Medilas D Multibeam Dornier Medilas D Litebeam + Dornier Medilas D30 Laser Dornier Medilas D FlexiPulse Dornier Medilas D Litebeam Diode Family of Lasers Dornier Medilas D60 Laser Dornier Medilas D Urobeam Genesis Gemini Delta III Lithotripter Compact Sigma Lithotripter Compact Alpha Lithotripter MPL Compact Delta Lithotripter MFL HM4 HM3 Gemini XXP-HP Genesis II

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-04-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-06-07
KQS Table, Cystometric, Non-Electric And Accessories Gastroenterology, Urology Class 1 876.4890 2008-03-26
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-09-26
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-03-26
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2015-10-30
LNS Lithotriptor, Extracorporeal Shock-Wave, Urological Gastroenterology, Urology Class 2 876.5990 2013-06-21
LNS Lithotriptor, Extracorporeal Shock-Wave, Urological Gastroenterology, Urology Class 2 876.5990 2017-08-17
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 1986-12-17
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-09-12
LNS Lithotriptor, Extracorporeal Shock-Wave, Urological Gastroenterology, Urology Class 2 876.5990 2008-03-26
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2009-12-22
LNS Lithotriptor, Extracorporeal Shock-Wave, Urological Gastroenterology, Urology Class 2 876.5990 2008-03-26
LNS Lithotriptor, Extracorporeal Shock-Wave, Urological Gastroenterology, Urology Class 2 876.5990 2015-10-30
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-08-27
LNS Lithotriptor, Extracorporeal Shock-Wave, Urological Gastroenterology, Urology Class 2 876.5990 2015-10-30
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-03-26
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2015-10-30
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-06-07
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-03-26

Official Correspondent

Dietmar Holzhammer

US Agent Details

John Hoffer Business: DORNIER MEDTECH AMERICA, INC. Email: jhoffer@dornier.com Phone: (770) 5146163

Related Public Records

Same Entity

DORNIER MEDTECH GMBH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0001-2007 GE OEC Medical Systems, Inc 2
GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009 Philips Medical Systems North America Co. Phillips 2
NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611388. Last updated year: 2026. Please use registration number 9611388 when referencing this establishment in official correspondence.
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