Sound Acoustic Systems, Ltd.
Country not established
- Devices
- 1
What Sound Acoustic Systems, Ltd. makes
Sound Acoustic Systems, Ltd. manufactures the EARLENS implantable device, a corneal inlay designed to correct myopia by reshaping the eye’s optical pathway for improved near and intermediate vision.
The EARLENS device is classified as Class I under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Earlens Ref K854311
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sound Acoustic Systems, Ltd. have in the registry?
The registry currently lists 1 device for Sound Acoustic Systems, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sound Acoustic Systems, Ltd.'s devices?
Among its 1 most recently registered device, Sound Acoustic Systems, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Sound Acoustic Systems, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sound Acoustic Systems, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sound Acoustic Systems, Ltd. in the registry?
The most recently registered devices listed for Sound Acoustic Systems, Ltd. include EARLENS.