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BC Applicator VRE2002

by Viora Ltd

BC Applicator VRE2002 is a Class II device made by Viora Ltd, cleared under FDA 510(k) K090221 on 1 Jul 2009 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07290016746327), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K090221

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290016746327 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090221 Date1 Jul 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090221 decided 1 Jul 2009 Active
  • FDA GUDID UDI-DI 07290016746327 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090221
  2. Listed FDA GUDID 07290016746327

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BC Applicator
Generic name
Multi-modality skin/body contouring system
Model / Ref / Catalog
VRE2002
Primary DI / UDI-DI
07290016746327
510(k) Number
FDA product code
ILY, ISA, NUV
GMDN term
Multi-modality skin/body contouring system
Device class
Class II
Regulation number
890.5500, 890.5660, 878.4810
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ILY (Lamp, Infrared, Therapeutic Heating).

Other devices from Viora Ltd

See all devices from Viora Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)