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FDA 510(k)

YandR System, VoluDerm Handpiece, VoluDerm Tips

K-Number: K220124 · 2022-02-17

ApplicantPollogen, Ltd.
Decision Date2022-02-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

YandR System, VoluDerm Handpiece, VoluDerm Tips is a medical device manufactured by Pollogen, Ltd.. It received FDA 510(k) clearance on 2022-02-17 under approval number K220124. 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 YandR System, VoluDerm Handpiece, VoluDerm Tips?

YandR System, VoluDerm Handpiece, VoluDerm Tips is a medical device that received FDA 510(k) clearance on 2022-02-17. It is manufactured by Pollogen, Ltd.. The 510(k) number is K220124.

When was YandR System, VoluDerm Handpiece, VoluDerm Tips approved by the FDA?

YandR System, VoluDerm Handpiece, VoluDerm Tips received FDA 510(k) clearance on 2022-02-17, under approval number K220124.

What company makes YandR System, VoluDerm Handpiece, VoluDerm Tips?

YandR System, VoluDerm Handpiece, VoluDerm Tips is manufactured by Pollogen, Ltd..

What is the FDA product code for YandR System, VoluDerm Handpiece, VoluDerm Tips?

The FDA product code for YandR System, VoluDerm Handpiece, VoluDerm Tips 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.

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