Solitec GmbH
GermanyFDA applicant, unverified
- Devices
- 3
What Solitec GmbH makes
Solitec GmbH manufactures UV-based medical devices for dermatological treatments, including the UVATEC SUNTAMED 4000 and 2000 series for controlled ultraviolet therapy, the UVATEC SUNTAMED 40 for localized UV exposure, and the DERMALIGHT PSORACOMB for targeted phototherapy in skin conditions.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Uvatec Suntamed 4000 And 2000 Ref K828671
Regimes: 510(k) Registry: 510(k)Uvatec Suntamed 400 Ref K828670
Regimes: 510(k) Registry: 510(k)Dermalight Psoracomb Ref K903660
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Solitec GmbH have in the registry?
The registry currently lists 3 devices for Solitec GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Solitec GmbH's devices?
Among its 3 most recently registered devices, Solitec GmbH has devices listed in FDA 510(k) (3 devices).
What risk classes do Solitec GmbH's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Solitec GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Solitec GmbH in the registry?
The most recently registered devices listed for Solitec GmbH include UVATEC SUNTAMED 4000 AND 2000, UVATEC SUNTAMED 400 and DERMALIGHT PSORACOMB.