Astralite Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Astralite Corp. makes
Astralite Corp. manufactures floor-standing, operating, and examining lights designed for surgical and clinical environments, as well as indirect laryngoscopes for visualizing the larynx during medical procedures.
Their products are classified as Class II medical devices under FDA regulations and are listed in the 510(k) premarket notification database. The company is based in the United States.
Catalogue
Floor Standing, Operating And Examining Light Ref K893813
Regimes: 510(k) Registry: 510(k)Lfre Indirect Laryngoscope Ref K023004
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Astralite Corp. have in the registry?
The registry currently lists 2 devices for Astralite Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Astralite Corp.'s devices?
Among its 2 most recently registered devices, Astralite Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Astralite Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Astralite Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Astralite Corp. in the registry?
The most recently registered devices listed for Astralite Corp. include FLOOR STANDING, OPERATING AND EXAMINING LIGHT and LFRE INDIRECT LARYNGOSCOPE.