Bostonsight
Country not established
- Devices
- 2
What Bostonsight makes
Bostonsight manufactures ocular prosthetics, including scleral prostheses designed to replace the eye’s natural globe and prosthetic devices for partial dentures (PD) to restore facial symmetry and function.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
BostonSight Scleral Ref K183175
510(k) 510(k)BostonSight PD Prosthetic Device Ref K161461
510(k) 510(k)
Frequently asked questions
How many devices does Bostonsight have in the registry?
The registry currently lists 2 devices for Bostonsight. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bostonsight's devices?
Among its 2 most recently registered devices, Bostonsight has devices listed in FDA 510(k) (2 devices).
What risk classes do Bostonsight's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bostonsight's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bostonsight in the registry?
The most recently registered devices listed for Bostonsight include BostonSight Scleral and BostonSight PD Prosthetic Device.