S&M Medical Co., Ltd.
South KoreaFDA 510(k) applicant, unverified FDA
- Devices
- 8
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What S&M Medical Co., Ltd. makes
S&M Medical Co., Ltd. manufactures the NeoSculpt Plus, a device designed for soft tissue augmentation or contouring procedures.
The NeoSculpt Plus is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
NeoSculpt Plus Ref K252888
510(k) 510(k)
FDA establishments
- S&M Medical Inc. Gwangju · KR FEI 3044778118
Frequently asked questions
How many devices does S&M Medical Co., Ltd. have in the registry?
The registry currently lists 8 devices for S&M Medical Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list S&M Medical Co., Ltd.'s devices?
Among its 8 most recently registered devices, S&M Medical Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do S&M Medical Co., Ltd.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for S&M Medical Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from S&M Medical Co., Ltd. in the registry?
The most recently registered devices listed for S&M Medical Co., Ltd. include NeoSculpt Plus Emergency Cable, NeoSculpt Plus Body, NeoSculpt Plus Handpiece 40 and NeoSculpt Plus Handpiece 16.
Which FDA establishments are linked to S&M Medical Co., Ltd.?
1 FDA establishment is linked to S&M Medical Co., Ltd. in the registry; they are listed on the company page.