Skin Deep, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Skin Deep, Inc. makes
Skin Deep, Inc. manufactures copper shank needles for dermatological procedures and sterilized electroepilation needles, designed for hair removal treatments. These devices are intended for single-use or reusable applications in clinical settings, targeting precision and patient comfort during procedures like electrolysis.
The company’s portfolio is classified under FDA Class I medical devices, requiring 510(k) clearance for market authorisation. Devices are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Flexie The Copper Shank Needle Ref K874891
Regimes: 510(k) Registry: 510(k)Wizard Sterilized Electroepilation Needle Ref K911983
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Skin Deep, Inc. have in the registry?
The registry currently lists 2 devices for Skin Deep, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Skin Deep, Inc.'s devices?
Among its 2 most recently registered devices, Skin Deep, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Skin Deep, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Skin Deep, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Skin Deep, Inc. in the registry?
The most recently registered devices listed for Skin Deep, Inc. include FLEXIE THE COPPER SHANK NEEDLE and WIZARD STERILIZED ELECTROEPILATION NEEDLE.