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510(k) K230968

VYBE RF Electrosurgical System by ShenB Co., Ltd. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2023
Date Received
April 5, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by ShenB Co., Ltd.

  • K251649 — Sunny Plus (Sunny) (September 18, 2025)
  • K242241 — Sunny (March 19, 2025)
  • K241535 — Vybe RF II (September 25, 2024)
  • K232223 — PlaDuo System (October 24, 2023)
  • K221363 — AF Laser (July 20, 2022)
  • K211562 — Virtue RF (November 23, 2021)
  • K193070 — VIVACE Electrosurgical Device (April 26, 2021)
  • K202415 — VirtueRF (January 22, 2021)
  • K201735 — PlaDuo System (December 14, 2020)

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