Ludek Optics, Inc.
Country not established
- Devices
- 1
What Ludek Optics, Inc. makes
Ludek Optics, Inc. manufactures the MAGNE-FIELD 400D OSTEO-BIO-NETIC SYSTEM, a device designed for orthopedic applications to support bone healing and tissue regeneration through electromagnetic stimulation.
The company’s portfolio is regulated under FDA Class II devices, with the MAGNE-FIELD 400D OSTEO-BIO-NETIC SYSTEM listed via a 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Magne-Field 400D Osteo-Bio-Netic Sys Ref K820995
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ludek Optics, Inc. have in the registry?
The registry currently lists 1 device for Ludek Optics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ludek Optics, Inc.'s devices?
Among its 1 most recently registered device, Ludek Optics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Ludek Optics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ludek Optics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ludek Optics, Inc. in the registry?
The most recently registered devices listed for Ludek Optics, Inc. include MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS.