ShenB Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
ShenB Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Diacore, Sunny Plus (Sunny), Sunny
11
Total
11
Cleared
0
Denied
ShenB Co., Ltd. has 11 FDA 510(k) cleared general & plastic surgery devices. Based in Seongdong-Gu, KR.
Latest FDA clearance: Apr 2026. Active since 2020.
Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Hoy and Associates, Hoy and Associates Regulatory Consulting and Aesthetics Biomedical.
FDA 510(k) Regulatory Record - ShenB Co., Ltd.
11 devices
Cleared
Apr 10, 2026
Diacore
Physical Medicine
123d
Cleared
Sep 18, 2025
Sunny Plus (Sunny)
Neurology
112d
Cleared
Mar 19, 2025
Sunny
General & Plastic Surgery
231d
Cleared
Sep 25, 2024
Vybe RF II
General & Plastic Surgery
118d
Cleared
Oct 24, 2023
PlaDuo System
General & Plastic Surgery
90d
Cleared
Jul 06, 2023
VYBE RF Electrosurgical System
General & Plastic Surgery
92d
Cleared
Jul 20, 2022
AF Laser
General & Plastic Surgery
70d
Cleared
Nov 23, 2021
Virtue RF
General & Plastic Surgery
187d
Cleared
Apr 26, 2021
VIVACE Electrosurgical Device
General & Plastic Surgery
539d
Cleared
Jan 22, 2021
VirtueRF
General & Plastic Surgery
151d
Cleared
Dec 14, 2020
PlaDuo System
General & Plastic Surgery
172d