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InMode RF™

by Inmode MD, Ltd.

Ref AG604881AModel AG613237A

InMode RF™ (AG604881A) is a device classified as Class IIb in the EU and Class II in the US made by Inmode MD, Ltd., registered in EUDAMED on 16 Jul 2026 (Basic UDI-DI 7290016633IRF100x92) with CE/MDR certificate 3903174CE02 valid until 1 Jul 2031, cleared under FDA 510(k) K151793 on 19 Feb 2016 and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 07290016633016), active as of 24 Oct 2026.

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

CE MDR CE MDD 510(k)

Valid until

1 Jul 2031

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

510(k) K151793

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3903174CE02 Date20 Jul 2026IssuedStatusActive expires 1 Jul 2031
European UnionCE/MDD EUDAMED Number7290016633IRF100x92 Basic UDI-DI 07290016633016UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016633016 UDI-DI Date25 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK151793 Date19 Feb 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7290016633IRF100x92 registered 16 Jul 2026 Active· +2 more in the status table
  • FDA 510(k) K151793 decided 19 Feb 2016 Active
  • FDA GUDID UDI-DI 07290016633016 listed 25 Oct 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3903174CE02 Active

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    20 Jul 2026
    Expires
    1 Jul 2031

Timeline

5 dated events

  1. Cleared FDA 510(k) K151793
  2. Listed FDA GUDID 07290016633016
  3. Registered EUDAMED 7290016633IRF100x92
  4. Certificate issued EUDAMED 3903174CE02
  5. Certificate expires EUDAMED 3903174CE02

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Percutaneous radio-frequency ablation system generator
Device name
IgniteRF system
Model / Ref / Catalog
AG613237A, AG604881A, InMode RF™
Primary DI / UDI-DI
07290016633016
Basic UDI-DI
7290016633IRF100x92, B-07290016633016
Direct marketing DI
07290016633016
510(k) Number
FDA product code
GEI
EMDN code
X0401, X0402, Z12040214
GMDN term
Percutaneous radio-frequency ablation system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
System or procedure pack
System which is a device in itself
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AG613237A
AG604881A
GUDID
InMode RF™
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: Percutaneous radio-frequency ablation system generator

Cleared under the same submission (K151793)

Similar devices in this category

Other devices filed under LIPOSUCTION SYSTEMS.

Other devices from Inmode MD, Ltd.

See all devices from Inmode MD, Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)