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Stop Vx Model U Stop U Model Uxv

by Pollogen Ltd

Stop Vx Model U Stop U Model Uxv (34650000BP-US) is a Class II device made by Pollogen Ltd, cleared under FDA 510(k) K203665 on 25 Feb 2021 and listed in FDA GUDID since 30 Jun 2021 (UDI-DI 07290016586442), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K203665

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290016586442 UDI-DI Date30 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK203665 Date25 Feb 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203665 decided 25 Feb 2021 Active
  • FDA GUDID UDI-DI 07290016586442 listed 30 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203665
  2. Listed FDA GUDID 07290016586442

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Stop Vx Model U
Generic name
Multi-modality skin/body contouring system
Model / Ref / Catalog
STOP U MODEL UXV, 34650000BP-US
Primary DI / UDI-DI
07290016586442
510(k) Number
FDA product code
PAY
GMDN term
Multi-modality skin/body contouring system
Device class
Class II
Regulation number
878.4420
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction).

Other devices from Pollogen Ltd

See all devices from Pollogen Ltd →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)