Vybe RF II
K-Number: K241535 · 2024-09-25
ApplicantShenB Co., Ltd.
Decision Date2024-09-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Vybe RF II is a medical device manufactured by ShenB Co., Ltd.. It received FDA 510(k) clearance on 2024-09-25 under approval number K241535. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vybe RF II?
Vybe RF II is a medical device that received FDA 510(k) clearance on 2024-09-25. It is manufactured by ShenB Co., Ltd.. The 510(k) number is K241535.
When was Vybe RF II approved by the FDA?
Vybe RF II received FDA 510(k) clearance on 2024-09-25, under approval number K241535.
What company makes Vybe RF II?
Vybe RF II is manufactured by ShenB Co., Ltd..
What is the FDA product code for Vybe RF II?
The FDA product code for Vybe RF II is GEI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.