Laser Optik Systeme GmbH & Co. KG
GermanyFDA applicant, unverified
- Devices
- 7
What Laser Optik Systeme GmbH & Co. KG makes
Laser Optik Systeme GmbH & Co. KG manufactures endoscopic imaging systems, including 3D vision endoscopes and portable endoscopy units. Their portfolio also includes cold light sources and xenon light sources designed for medical procedures, supporting flexible and rigid endoscope applications.
The company’s devices are classified under FDA categories Class I and Class II, with submissions recorded in the FDA’s 510(k) registry. These products are intended for use in the United States, where regulatory compliance is tracked through the 510(k) clearance process.
Catalogue
Los 3D Vision 100 Ref K930965
Regimes: 510(k) Registry: 510(k)Standard Endoscope Ref K972056
Regimes: 510(k) Registry: 510(k)Los 3D Vision 100 Ref K953419
Regimes: 510(k) Registry: 510(k)Cold Light Source Los Xl-A 100 Ref K952028
Regimes: 510(k) Registry: 510(k)Portable Endoscopy System Ref K950712
Regimes: 510(k) Registry: 510(k)Cold Light Source Los 150 Ref K951829
Regimes: 510(k) Registry: 510(k)Xenon Light Source Pes 1 Ref K992540
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Laser Optik Systeme GmbH & Co. KG have in the registry?
The registry currently lists 7 devices for Laser Optik Systeme GmbH & Co. KG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Laser Optik Systeme GmbH & Co. KG's devices?
Among its 7 most recently registered devices, Laser Optik Systeme GmbH & Co. KG has devices listed in FDA 510(k) (7 devices).
What risk classes do Laser Optik Systeme GmbH & Co. KG's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Laser Optik Systeme GmbH & Co. KG's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Laser Optik Systeme GmbH & Co. KG in the registry?
The most recently registered devices listed for Laser Optik Systeme GmbH & Co. KG include LOS 3D VISION 100, STANDARD ENDOSCOPE, COLD LIGHT SOURCE LOS XL-A 100 and PORTABLE ENDOSCOPY SYSTEM.