R2 Dermatology
Country not established
- Devices
- 2
What R2 Dermatology makes
R2 Dermatology manufactures dermal cooling systems designed for skin treatment applications, including temporary relief of pain or inflammation. These devices are intended for non-invasive use on the skin surface to reduce thermal discomfort or swelling.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. The systems are listed in the FDA’s 510(k) registry. The manufacturer operates from the United States.
Catalogue
Dermal Cooling System Ref K171398
510(k) 510(k)R2 Dermal Cooling System Ref K161480
510(k) 510(k)
Frequently asked questions
How many devices does R2 Dermatology have in the registry?
The registry currently lists 2 devices for R2 Dermatology. Devices recorded under merged duplicate company entries are counted once.
Which registries list R2 Dermatology's devices?
Among its 2 most recently registered devices, R2 Dermatology has devices listed in FDA 510(k) (2 devices).
What risk classes do R2 Dermatology's devices fall under?
Among its 2 most recently registered devices, the classes recorded for R2 Dermatology's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from R2 Dermatology in the registry?
The most recently registered devices listed for R2 Dermatology include Dermal Cooling System and R2 Dermal Cooling System.