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EMPOWER ENVISION InMode RF PRO

by Inmode MD, Ltd.

Ref AG609482A

EMPOWER ENVISION InMode RF PRO (AG609482A) is a device classified as Class IIa in the EU and Class II in the US made by Inmode MD, Ltd., registered in EUDAMED on 2 Mar 2025 (Basic UDI-DI 7290016633EMS800V93) with CE/MDR certificate 3903174CE01 valid until 1 Feb 2030, cleared under FDA 510(k) K210492 on 12 Jul 2021 and listed in FDA GUDID since 15 Jul 2021 (UDI-DI 07290016633665), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

1 Feb 2030

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

510(k) K210492

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3903174CE01 Date10 Jun 2026IssuedStatusActive expires 1 Feb 2030
United StatesGUDID listing GUDID Number07290016633665 UDI-DI Date15 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK210492 Date12 Jul 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7290016633EMS800V93 registered 2 Mar 2025 Active· +1 more in the status table
  • FDA 510(k) K210492 decided 12 Jul 2021 Active
  • FDA GUDID UDI-DI 07290016633665 listed 15 Jul 2021 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3903174CE01 Active Amended

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    10 Jun 2026
    Expires
    1 Feb 2030
    Reason
    Mnf ar change

Timeline

5 dated events

  1. Cleared FDA 510(k) K210492
  2. Listed FDA GUDID 07290016633665
  3. Registered EUDAMED 7290016633EMS800V93
  4. Certificate issued EUDAMED 3903174CE01
  5. Certificate expires EUDAMED 3903174CE01

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Empower Envision
Generic name
Percutaneous radio-frequency ablation system generator
Device name
InMode RF Pro with vTone hand piece
Model / Ref / Catalog
AG609482A, InMode RF PRO
Primary DI / UDI-DI
07290016633665
Basic UDI-DI
7290016633EMS800V93
Direct marketing DI
07290016633665
510(k) Number
FDA product code
GEI
EMDN code
U070302 Pelvic floor rehabilitation devices, functional electrostimulation, single-use
GMDN term
Percutaneous radio-frequency ablation system generator
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4400
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AG609482A
GUDID
InMode RF PRO
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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 (K210492)

and 6 more cleared under K210492

Similar devices in this category

Other devices filed under PELVIC FLOOR REHABILITATION DEVICES.

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)