The Helene Edgar Corp.
CanadaFDA applicant, unverified
- Devices
- 1
What The Helene Edgar Corp. makes
The Helene Edgar Corp. manufactures the Commander Mark II Hair Removal System, a device designed for professional and at-home hair removal using electrolysis technology. It targets individual hair follicles to provide permanent hair reduction through precise thermal destruction.
The Commander Mark II is classified as a Class I medical device under FDA regulations and has been authorised via the 510(k) clearance process. The company is based in the United States.
Catalogue
Commander Mark Ii Hair Removal System Ref K943872
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does The Helene Edgar Corp. have in the registry?
The registry currently lists 1 device for The Helene Edgar Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list The Helene Edgar Corp.'s devices?
Among its 1 most recently registered device, The Helene Edgar Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do The Helene Edgar Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for The Helene Edgar Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from The Helene Edgar Corp. in the registry?
The most recently registered devices listed for The Helene Edgar Corp. include COMMANDER MARK II HAIR REMOVAL SYSTEM.