Wavelight Laser Technologie AG
Country not established
- Devices
- 8
What Wavelight Laser Technologie AG makes
Wavelight Laser Technologie AG manufactures excimer laser systems for refractive eye surgery, including devices for corneal reshaping procedures such as photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK). Their portfolio includes systems designed for customised vision correction, such as the Wavelight Auriga and Wavelight Sinon, which incorporate advanced imaging and ablation technologies. Other devices, like the Arion and Burane XL, are tailored for specific surgical applications, including wavefront-guided treatments and corneal cross-linking. The MYDON C and Burane systems support diagnostic and treatment workflows in ophthalmology.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) registry, reflecting their compliance with US regulatory requirements. The manufacturer operates from the United States.
Catalogue
Wavelight Auriga Ref K051399
Regimes: 510(k) Registry: 510(k)Wavelight Sinon Ref K050218
Regimes: 510(k) Registry: 510(k)Sinon Ref K040433
Regimes: 510(k) Registry: 510(k)Arion Ref K042474
Regimes: 510(k) Registry: 510(k)Burane Xl Ref K050317
Regimes: 510(k) Registry: 510(k)Mydon C Ref K040384
Regimes: 510(k) Registry: 510(k)Burane Ref K052806
Regimes: 510(k) Registry: 510(k)Wavelight Idas Ref K053604
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Wavelight Laser Technologie AG have in the registry?
The registry currently lists 8 devices for Wavelight Laser Technologie AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wavelight Laser Technologie AG's devices?
Among its 8 most recently registered devices, Wavelight Laser Technologie AG has devices listed in FDA 510(k) (8 devices).
What risk classes do Wavelight Laser Technologie AG's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Wavelight Laser Technologie AG's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wavelight Laser Technologie AG in the registry?
The most recently registered devices listed for Wavelight Laser Technologie AG include WAVELIGHT AURIGA, WAVELIGHT SINON, SINON and ARION.