Skip to content

TriLift

by Pollogen Ltd

Ref 30020000BK

TriLift (30020000BK) is a device classified as Class IIb in the EU and Class II in the US made by Pollogen Ltd, registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI B-07290016586534), cleared under FDA 510(k) K232903 on 17 Oct 2023 (2 earlier submissions) and listed in FDA GUDID since 13 Feb 2022 (UDI-DI 07290016586534), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232903

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290016586534 Basic UDI-DI 07290016586534UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK232903 Date17 Oct 2023DecidedStatusActive
United StatesGUDID listing GUDID Number07290016586534 UDI-DI Date13 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290016586534 registered 4 Aug 2026 Active
  • FDA 510(k) K232903 decided 17 Oct 2023 Active· +2 more in the status table
  • FDA GUDID UDI-DI 07290016586534 listed 13 Feb 2022 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K173503
  2. Cleared FDA 510(k) K200545
  3. Listed FDA GUDID 07290016586534
  4. Cleared FDA 510(k) K232903
  5. Registered EUDAMED B-07290016586534

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Radio-frequency skin surface treatment/fat liquefaction system control unit
Model / Ref / Catalog
30020000BK, TriLift
Primary DI / UDI-DI
07290016586534
Basic UDI-DI
B-07290016586534
FDA product code
NGX, GEI
EMDN code
Z12040280, Z12040299
GMDN term
Radio-frequency skin surface treatment/fat liquefaction system control unit
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
890.5850, 878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
30020000BK
GUDID
TriLift
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Radio-frequency skin surface treatment/fat liquefaction system control unit

Cleared under the same submission (K173503)

and 8 more cleared under K173503

Similar devices in this category

Other devices filed under GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS.

Other devices from Pollogen Ltd

See all devices from Pollogen Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)