Keosan Trading Co.
South KoreaFDA applicant, unverified
- Devices
- 2
What Keosan Trading Co. makes
Keosan Trading Co. manufactures customized silicone breast implants, including the FITme and MISTI lines, designed for reconstructive and cosmetic surgical procedures. These devices are intended for use in procedures requiring tailored sizing and shape to match patient anatomy.
The company’s silicone implants are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they are subject to FDA oversight.
Catalogue
FITme Customized Silicone Implant Ref K232593
Regimes: 510(k) Registry: 510(k)MISTI Silicone Implant Ref K241150
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Keosan Trading Co. have in the registry?
The registry currently lists 2 devices for Keosan Trading Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Keosan Trading Co.'s devices?
Among its 2 most recently registered devices, Keosan Trading Co. has devices listed in FDA 510(k) (2 devices).
What risk classes do Keosan Trading Co.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Keosan Trading Co.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Keosan Trading Co. in the registry?
The most recently registered devices listed for Keosan Trading Co. include FITme Customized Silicone Implant and MISTI Silicone Implant.