Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STOP U Model UXV Device

K-Number: K203665 · 2021-02-25

ApplicantPollogen, Ltd.
Decision Date2021-02-25
Product CodePAY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STOP U Model UXV Device is a medical device manufactured by Pollogen, Ltd.. It received FDA 510(k) clearance on 2021-02-25 under approval number K203665. 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 STOP U Model UXV Device?

STOP U Model UXV Device is a medical device that received FDA 510(k) clearance on 2021-02-25. It is manufactured by Pollogen, Ltd.. The 510(k) number is K203665.

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

STOP U Model UXV Device received FDA 510(k) clearance on 2021-02-25, under approval number K203665.

What company makes STOP U Model UXV Device?

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

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

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

Related Clinical Trials

NCT06291818 Self-Adhering Magnetic Device to Treat Corneal Exposure RECRUITING NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT06377007 Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION) COMPLETED NCT06969560 WeRoaM: Wearable Remote Monitoring in Heart Failure RECRUITING NCT05116176 TRAjectories and CLinical ExpeRiences of ICD Therapy Study ENROLLING_BY_INVITATION

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 K220124YandR System, VoluDerm Handpiece, VoluDerm Tips K232903Legend X Platform

View all 14 devices →

Related Devices (Code: PAY)

K170499sensiLiftEl Global Trade, Ltd. K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. K230013Silk'n Titan AllwaysSilk'N Beauty , Ltd. K220322Pollogen STOP U Model UXV DevicePollogen, 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.

↑