Theralight, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Theralight, Inc. makes
Theralight, Inc. manufactures phototherapy systems designed for UVA/UVB light treatment, including the UV120-2 UVA/UVB Phototherapy System, and skin therapy devices like the VersaClear Skin Therapy System (Model 100). These devices are intended for controlled light-based medical treatments.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. Theralight, Inc. is based in the United States.
Catalogue
Theralight UV120-2 Uva/Uvb Phototherapy System Ref K024020
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Versaclear Skin Therapy System, Model 100 Ref K061295
Regimes: 510(k) Registry: 510(k)Versaclear Skin Therapy System, Model 100 Ref K051259
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Theralight, Inc. have in the registry?
The registry currently lists 4 devices for Theralight, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Theralight, Inc.'s devices?
Among its 4 most recently registered devices, Theralight, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Theralight, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Theralight, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Theralight, Inc. in the registry?
The most recently registered devices listed for Theralight, Inc. include THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2 and VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100.