Diomedics, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Diomedics, Inc. makes
Diomedics, Inc. manufactures surgical lighting systems, including the VERSA LITE portable surgical light and optical fiber bundles for surgical illumination, such as the SURGI LIGHT/LIGHT TOUCH fibers. The company also produces the PHASER-2000, a device used in surgical procedures for precise tissue treatment.
These devices are classified as Class II under FDA regulations and are recorded in the 510(k) clearance registry. The company is based in the United States.
Catalogue
Versa Lite Ref K073503
Regimes: 510(k) Registry: 510(k)Diomedics Surgi Light/Light Touch Optical Fibers Ref K926224
Regimes: 510(k) Registry: 510(k)Phaser-2000 Ref K982546
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diomedics, Inc. have in the registry?
The registry currently lists 3 devices for Diomedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diomedics, Inc.'s devices?
Among its 3 most recently registered devices, Diomedics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Diomedics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Diomedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diomedics, Inc. in the registry?
The most recently registered devices listed for Diomedics, Inc. include VERSA LITE, DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS and PHASER-2000.