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SR Hand piece VTR2002

by Viora Ltd

SR Hand piece VTR2002 is a Class II device made by Viora Ltd, cleared under FDA 510(k) K090399 on 10 Jun 2009 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07290016746389), 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) K090399

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 Number07290016746389 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090399 Date10 Jun 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090399 decided 10 Jun 2009 Active
  • FDA GUDID UDI-DI 07290016746389 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090399
  2. Listed FDA GUDID 07290016746389

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SR Hand piece
Generic name
Intense pulsed light skin surface treatment system
Model / Ref / Catalog
VTR2002
Primary DI / UDI-DI
07290016746389
510(k) Number
FDA product code
ONF
GMDN term
Intense pulsed light skin surface treatment system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect).

Other devices from Viora Ltd

See all devices from Viora Ltd →

Properties

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