BC Large Applicator VTL45920: CE/MDD Class IIb, Viora Ltd

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-07290016746266 Basic UDI-DI 07290016746266UDI-DI	Date24 Jun 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK162363	Date18 Nov 2016Decided	StatusActive
United States	GUDID listing GUDID	Number07290016746266 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK152611	Date19 Feb 2016Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK150035	Date1 May 2015Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-07290016746266 — open Devices and search for it
AccessGUDID record UDI-DI 07290016746266
FDA 510(k) database 510(k) number K162363
FDA 510(k) database 510(k) number K152611
FDA 510(k) database 510(k) number K150035

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-07290016746266 registered 24 Jun 2026 Active
FDA 510(k) K162363 decided 18 Nov 2016 Active· +2 more in the status table
FDA GUDID UDI-DI 07290016746266 listed 23 Sep 2016 Listed

Timeline

5 dated events

1 May 2015 Cleared FDA 510(k) K150035
19 Feb 2016 Cleared FDA 510(k) K152611
23 Sep 2016 Listed FDA GUDID 07290016746266
18 Nov 2016 Cleared FDA 510(k) K162363
24 Jun 2026 Registered EUDAMED B-07290016746266

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

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

Specification

EUDAMED · GUDID

Trade name: BC Large Applicator
Generic name: Multi-modality skin/body contouring system
Model / Ref / Catalog: VTL45920, BC Large Applicator

Primary DI / UDI-DI: 07290016746266
Basic UDI-DI: B-07290016746266
510(k) Number: K150035
K152611
K162363
FDA product code: PBX, ISA
EMDN code: V9099 Various devices not included in other classes - other
GMDN term: Multi-modality skin/body contouring system

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 878.4400, 890.5660
System or procedure pack: System which is a device in itself
EU registration type: Legacy device (under a directive)
EU market of registration: Germany
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.