Lumalite, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Lumalite, Inc. makes
Lumalite, Inc. manufactures dental curing lights, including the VERACAM system and standalone models like the LUMALITE CURE LIGHT (Model 2100) and LUMA LIGHT 2000. These devices are designed for polymerizing composite resins in dental restorations, ensuring proper curing of dental materials.
The company’s portfolio includes Class I and Class II devices, all of which are listed under the FDA’s 510(k) pathway. These products are regulated under U.S. medical device laws and are intended for use within the United States.
Catalogue
Veracam Ref K021083
Regimes: 510(k) Registry: 510(k)Lumalite Cure Light, Model 2100 Ref K002566
Regimes: 510(k) Registry: 510(k)Luma Light 2000 Cure Light Ref K992102
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lumalite, Inc. have in the registry?
The registry currently lists 3 devices for Lumalite, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lumalite, Inc.'s devices?
Among its 3 most recently registered devices, Lumalite, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Lumalite, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Lumalite, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lumalite, Inc. in the registry?
The most recently registered devices listed for Lumalite, Inc. include VERACAM, LUMALITE CURE LIGHT, MODEL 2100 and LUMA LIGHT 2000 CURE LIGHT.