Eleme Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Eleme Medical, Inc. makes
Eleme Medical, Inc. manufactures the SMOOTHSHAPES System (models 11318-120V and 11319-230V), a device for shaping and smoothing tissue, and the SMOOTHLIPO and SMOOTHSHAPES standalone devices, designed for cosmetic and surgical applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Smoothshapes System, 11318-120V, 11319-230V Ref K100230
Regimes: 510(k) Registry: 510(k)Smoothlipo Ref K083478
Regimes: 510(k) Registry: 510(k)Smoothshapes Ref K083629
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Eleme Medical, Inc. have in the registry?
The registry currently lists 3 devices for Eleme Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eleme Medical, Inc.'s devices?
Among its 3 most recently registered devices, Eleme Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Eleme Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Eleme Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Eleme Medical, Inc. in the registry?
The most recently registered devices listed for Eleme Medical, Inc. include SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V, SMOOTHLIPO and SMOOTHSHAPES.