Wavelight AG
GermanyFDA applicant, unverified FDA FEI 3010300699
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Wavelight AG makes
Wavelight AG manufactures the Allegro Oculyzer, a device used for corneal topography and wavefront analysis in ophthalmology to assess and map the surface curvature of the eye and optical aberrations.
The Allegro Oculyzer is classified as a Class II medical device and is listed under the FDA’s 510(k) clearance process. The company is based in the United States.
Catalogue
Allegro Oculyzer Ref K071183
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3010300699
- Address
- Rheinstrasse 8, Teltow Brandenburg
FDA recalls
FDA recall records list 1 recall initiated by Wavelight AG, initiated on 2011-04-18. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 18 Apr 2011 Z-2292-2011 Unclassified (pre-2012) Terminated The software calculating the patterns were found to has a rounding error for certain parameter ranges. These rounding errors could result in an incomplete cut in the donor or patient tissue.
Full distribution text
- 18 Apr 2011 Z-2292-2011 Unclassified (pre-2012) Terminated The software calculating the patterns were found to has a rounding error for certain parameter ranges. These rounding errors could result in an incomplete cut in the donor or patient tissue.
Frequently asked questions
How many devices does Wavelight AG have in the registry?
The registry currently lists 1 device for Wavelight AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wavelight AG's devices?
Among its 1 most recently registered device, Wavelight AG has devices listed in FDA 510(k) (1 device).
What risk classes do Wavelight AG's devices fall under?
Among its 1 most recently registered device, the classes recorded for Wavelight AG's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Wavelight AG?
FDA recall records list 1 recall initiated by Wavelight AG, the most recent initiated on 18 Apr 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Wavelight AG in the registry?
The most recently registered devices listed for Wavelight AG include ALLEGRO OCULYZER.