Sae Biang Optical Co.
South KoreaFDA applicant, unverified
- Devices
- 1
What Sae Biang Optical Co. makes
Sae Biang Optical Co. manufactures spectacle frames designed for eyewear, including standard and custom-fit options for adult and pediatric use.
These products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Spectacle Frames Ref K935968
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sae Biang Optical Co. have in the registry?
The registry currently lists 1 device for Sae Biang Optical Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sae Biang Optical Co.'s devices?
Among its 1 most recently registered device, Sae Biang Optical Co. has devices listed in FDA 510(k) (1 device).
What risk classes do Sae Biang Optical Co.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sae Biang Optical Co.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sae Biang Optical Co. in the registry?
The most recently registered devices listed for Sae Biang Optical Co. include SPECTACLE FRAMES.