# ShenB Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 11 (2020–2026): 11 510(k) clearances
- Product codes: GEI (8), NFO (1), NGX (1), PDZ (1)
- 510(k) review time since 2016: median 137 days, against 121 for FDA's reviews in the same codes and years (4 of 10 faster)
- Predicates its devices cite: 12 (5 its own); citations of its devices by later devices: 12 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sung Hwan E&B Co.,Ltd: 2 (https://510kreport.com/company/sung-hwan-e-b)
- Tama Research Corporation: 1 (https://510kreport.com/company/tama-research)
- Jeisys Medical, Inc.: 1 (https://510kreport.com/company/jeisys-medical)
- Solta Medical, Inc.: 1 (https://510kreport.com/company/solta-medical)
- Hebei JT Medical Co., Ltd.: 1 (https://510kreport.com/company/hebei-jt-medical)
- Erchonia Medical, Inc.: 1 (https://510kreport.com/company/erchonia-medical)

## Firms that cite its devices most
- Terasysd&C, Inc.: 1 (https://510kreport.com/company/terasysd-c)
- Agnes Medical Co., Ltd.: 1 (https://510kreport.com/company/agnes-medical)
- Chungwoo Co., Ltd.: 1 (https://510kreport.com/company/chungwoo)
- Triworks Group Srl: 1 (https://510kreport.com/company/triworks-group)
- Medicell Healthcare Co.,LTD: 1 (https://510kreport.com/company/medicell-healthcare)
- Shenzhen Gsd Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-gsd-technology)
- Ellian Corp: 1 (https://510kreport.com/company/ellian)

## Its most-cited devices
- K193070: VIVACE Electrosurgical Device (2021), cited by 3
- K201735: PlaDuo System (2020), cited by 3
- K211562: Virtue RF (2021), cited by 2
- K221363: AF Laser (2022), cited by 2
- K202415: VirtueRF (2021), cited by 1
- K230968: VYBE RF Electrosurgical System (2023), cited by 1

## Recent decisions
- K253926: Diacore (Apr 10, 2026)
- K251649: Sunny Plus (Sunny) (Sep 18, 2025)
- K242241: Sunny (Mar 19, 2025)
- K241535: Vybe RF II (Sep 25, 2024)
- K232223: PlaDuo System (Oct 24, 2023)
- K230968: VYBE RF Electrosurgical System (Jul 6, 2023)
- K221363: AF Laser (Jul 20, 2022)
- K211562: Virtue RF (Nov 23, 2021)

Source page: https://510kreport.com/company/shenb