Medical Device Manufacturer · KR , Seongdong-Gu

ShenB Co., Ltd.

10 submissions · 10 cleared · Since 2020
10
Total
10
Cleared
0
Denied

ShenB Co., Ltd. — FDA 510(k) Submissions

ShenB Co., Ltd. has submitted 10 FDA 510(k) premarket notifications since 2020, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis, Stimulator, Transcutaneous Electrical, Aesthetic Purposes . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
Sunny Plus (Sunny)
K251649 · NFO Stimulator,... · Neurology
Sep 2025 112d
Sunny
K242241 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 2025 231d
Vybe RF II
K241535 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Sep 2024 118d
PlaDuo System
K232223 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2023 90d
VYBE RF Electrosurgical System
K230968 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jul 2023 92d
AF Laser
K221363 · PDZ Lasers For Temporary... · General & Plastic Surgery
Jul 2022 70d
Virtue RF
K211562 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Nov 2021 187d
VIVACE Electrosurgical Device
K193070 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2021 539d
VirtueRF
K202415 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2021 151d
PlaDuo System
K201735 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2020 172d
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