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FDA 510(k)

Pollogen STOP U Model UXV Device

K-Number: K220322 · 2023-05-04

ApplicantPollogen, Ltd.
Decision Date2023-05-04
Product CodePAY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pollogen STOP U Model UXV Device is a medical device manufactured by Pollogen, Ltd.. It received FDA 510(k) clearance on 2023-05-04 under approval number K220322. The device is classified under product code PAY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pollogen STOP U Model UXV Device?

Pollogen STOP U Model UXV Device is a medical device that received FDA 510(k) clearance on 2023-05-04. It is manufactured by Pollogen, Ltd.. The 510(k) number is K220322.

When was Pollogen STOP U Model UXV Device approved by the FDA?

Pollogen STOP U Model UXV Device received FDA 510(k) clearance on 2023-05-04, under approval number K220322.

What company makes Pollogen STOP U Model UXV Device?

Pollogen STOP U Model UXV Device is manufactured by Pollogen, Ltd..

What is the FDA product code for Pollogen STOP U Model UXV Device?

The FDA product code for Pollogen STOP U Model UXV Device is PAY.

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 40408133 A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study. Journal of medical Internet research (2025)

Other Devices by Pollogen, Ltd.

K171359Pollogen Legend+ System 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

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Related Devices (Code: PAY)

K170499sensiLiftEl Global Trade, Ltd. K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. K203665STOP U Model UXV DevicePollogen, Ltd. K230013Silk'n Titan AllwaysSilk'N Beauty , Ltd. K222012FAQ 101Foreo, Inc. K240616FAQ™ (102)Foreo, Inc.

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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