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V-Nd:YAG HP Basic VTL44030

by Viora Ltd

V-Nd:YAG HP Basic VTL44030 is a Class II device made by Viora Ltd, cleared under FDA 510(k) K133837 on 9 Apr 2014 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07290016746174), 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) K133837

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 Number07290016746174 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133837 Date9 Apr 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133837 decided 9 Apr 2014 Active
  • FDA GUDID UDI-DI 07290016746174 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133837
  2. Listed FDA GUDID 07290016746174

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
V-Nd:YAG HP Basic
Generic name
Dermatological laser beam guiding handpiece
Model / Ref / Catalog
VTL44030
Primary DI / UDI-DI
07290016746174
510(k) Number
FDA product code
GEX
GMDN term
Dermatological laser beam guiding handpiece
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

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Properties

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