Data / Medical devices / South Korea / ShenB Co Ltd
ShenB Co Ltd: FDA-registered device maker in Seongdong-gu Seoul, South Korea, 7 510(k) clearances
ShenB Co Ltd is registered with the FDA (registration 3010226575) in Seongdong-gu Seoul, South Korea. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010226575
- Address
- SHENB Tower, 74, Achasan-ro, Seongdong-gu Seoul, South Korea, 04782
- Owner or operator
- ShenB Co Ltd (10051010)
- Roles
- Manufacturer
- First device listed
- May 6, 2021
- Registered through
- 2026
- Brand names listed
- PlaDuo PRO System, PlaDuo System, Sunny, Sunny Plus (Sunny), VIVACE, VIVACE PRO, VYBE RF, VYBE RF II and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 18, 2025 | K251649 | Sunny Plus (Sunny) | NFO | Substantially Equivalent | ShenB Co., Ltd. | accessdata.fda.gov |
| March 19, 2025 | K242241 | Sunny | GEI | Substantially Equivalent | ShenB Co., Ltd. | accessdata.fda.gov |
| September 25, 2024 | K241535 | Vybe RF II | GEI | Substantially Equivalent | ShenB Co., Ltd. | accessdata.fda.gov |
| October 24, 2023 | K232223 | PlaDuo System | GEI | Substantially Equivalent | ShenB Co., Ltd. | accessdata.fda.gov |
| July 6, 2023 | K230968 | VYBE RF Electrosurgical System | GEI | Substantially Equivalent | ShenB Co., Ltd. | accessdata.fda.gov |
| November 23, 2021 | K211562 | Virtue RF | GEI | Substantially Equivalent | ShenB Co., Ltd. | accessdata.fda.gov |
| April 26, 2021 | K193070 | VIVACE Electrosurgical Device | GEI | Substantially Equivalent | ShenB Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Updated September 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.