FDA 510(k)

Pollogen Legend+ System

K-Number: K171359 · 2017-09-13

Decision Date2017-09-13

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Pollogen Legend+ System is a medical device manufactured by Pollogen, Ltd.. It received FDA 510(k) clearance on 2017-09-13 under approval number K171359. 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 Pollogen Legend+ System?

Pollogen Legend+ System is a medical device that received FDA 510(k) clearance on 2017-09-13. It is manufactured by Pollogen, Ltd.. The 510(k) number is K171359.

When was Pollogen Legend+ System approved by the FDA?

Pollogen Legend+ System received FDA 510(k) clearance on 2017-09-13, under approval number K171359.

What company makes Pollogen Legend+ System?

Pollogen Legend+ System is manufactured by Pollogen, Ltd..

What is the FDA product code for Pollogen Legend+ System?

The FDA product code for Pollogen Legend+ System is GEI.

Other Devices by Pollogen, Ltd.

K173503Pollogen Legend System K182774STOP U (Packed Black USA), STOP U (Packed White USA) K200545Legend Pro DMA K203665STOP U Model UXV Device K220124YandR System, VoluDerm Handpiece, VoluDerm Tips K232903Legend X Platform

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.