Harpar Grace International
United KingdomFDA applicant, unverified
- Devices
- 1
What Harpar Grace International makes
Harpar Grace International manufactures the Shani Darden LED light therapy mask, a device designed for skin rejuvenation and treatment of conditions like acne and rosacea through controlled light exposure.
The company’s portfolio is regulated under FDA’s Class II device classification, with the Shani Darden LED light therapy mask authorised via the 510(k) pathway. The device is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Shani Darden LED light therapy mask Ref K214103
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Harpar Grace International have in the registry?
The registry currently lists 1 device for Harpar Grace International. Devices recorded under merged duplicate company entries are counted once.
Which registries list Harpar Grace International's devices?
Among its 1 most recently registered device, Harpar Grace International has devices listed in FDA 510(k) (1 device).
What risk classes do Harpar Grace International's devices fall under?
Among its 1 most recently registered device, the classes recorded for Harpar Grace International's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Harpar Grace International in the registry?
The most recently registered devices listed for Harpar Grace International include Shani Darden LED light therapy mask.