Ignite RF System AG613237A: CE/MDD Class IIb

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number3903174CE02	Date20 Jul 2026Issued	StatusActive expires 1 Jul 2031
European Union	CE/MDD EUDAMED	Number7290016633IRF100x92 Basic UDI-DI 07290019863250UDI-DI	Date16 Jul 2026Registered	StatusActive
European Union	CE/MDR EUDAMED	Number7290016633IRF100x92 Basic UDI-DI 07290019863250UDI-DI	Date16 Jul 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK251254	Date15 Jan 2026Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK240780	Date24 Jul 2024Decided	StatusActive
United States	GUDID listing GUDID	Number07290019863250 UDI-DI	Date24 Mar 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK233642	Date20 Mar 2024Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK182325	Date26 Sep 2018Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 7290016633IRF100x92 — open Devices and search for it
AccessGUDID record UDI-DI 07290019863250
FDA 510(k) database 510(k) number K251254
FDA 510(k) database 510(k) number K240780
FDA 510(k) database 510(k) number K233642
FDA 510(k) database 510(k) number K182325

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) K251254 decided 15 Jan 2026 Active· +3 more in the status table
FDA GUDID UDI-DI 07290019863250 listed 24 Mar 2024 Listed

Certificates

1 certificate · EUDAMED

3903174CE02 Active

Quality management system EU MDR

Certifier

DEKRA Certification B.V. 0344

Issued
20 Jul 2026

Expires
1 Jul 2031

Timeline

8 dated events

26 Sep 2018 Cleared FDA 510(k) K182325
20 Mar 2024 Cleared FDA 510(k) K233642
24 Mar 2024 Listed FDA GUDID 07290019863250
24 Jul 2024 Cleared FDA 510(k) K240780
15 Jan 2026 Cleared FDA 510(k) K251254
16 Jul 2026 Registered EUDAMED 7290016633IRF100x92
20 Jul 2026 Certificate issued EUDAMED 3903174CE02
1 Jul 2031 Certificate expires EUDAMED 3903174CE02

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR, CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: IgniteRF System EUDAMED
Ignite RF System GUDID
Generic name: Multi-modality skin surface treatment system
Device name: IgniteRF
Model / Ref / Catalog: AG613237A

Primary DI / UDI-DI: 07290019863250
Basic UDI-DI: 7290016633IRF100x92, B-07290019863250
Direct marketing DI: 07290019863250
510(k) Number: K182325
K233642
K240780
K251254
FDA product code: GEI
EMDN code: X0401, X0402, Z12040214
GMDN term: Multi-modality skin surface treatment system

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: Italy
France
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED 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.