Ultralite
Country not established
- Devices
- 6
What Ultralite makes
Ultralite manufactures ultraviolet (UV) light devices, including handheld systems for hand and foot treatments, panel-mounted UV units, and psoralen-phototherapy systems. Their products are designed for medical applications such as psoriasis and vitiligo treatment, utilizing UVB and UVA light sources at specific wavelengths (e.g., 305nm, 350nm). The SPECTRA series covers both standalone UV units and combined UV/psoralen systems, while the ULTRALITE PANELITE provides fixed-panel UV exposure solutions.
Ultralite’s devices are classified as Class II under FDA regulations and require 510(k) clearance for market authorisation. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with US regulatory requirements. The company operates from the United States, adhering to domestic medical device standards.
Catalogue
SPECTRA305 Ref K820492
Regimes: 510(k) Registry: 510(k)Ultralite HF1236 Hand And Foot System Ref K861963
Regimes: 510(k) Registry: 510(k)Spectra (Ultraviolet Products) Ref K827123
Regimes: 510(k) Registry: 510(k)Spectra 305/350 Ref K820280
Regimes: 510(k) Registry: 510(k)Ultralite Panelite Ref K910091
Regimes: 510(k) Registry: 510(k)Psoralite Ref K761179
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ultralite have in the registry?
The registry currently lists 6 devices for Ultralite. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ultralite's devices?
Among its 6 most recently registered devices, Ultralite has devices listed in FDA 510(k) (6 devices).
What risk classes do Ultralite's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Ultralite's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ultralite in the registry?
The most recently registered devices listed for Ultralite include SPECTRA305, ULTRALITE HF1236 HAND AND FOOT SYSTEM, SPECTRA (ULTRAVIOLET PRODUCTS) and SPECTRA 305/350.