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V-Laser

by Wontech Co., Ltd

V-Laser is a Class II device made by Wontech Co., Ltd, cleared under FDA 510(k) K221427 on 24 Aug 2022 (1 earlier submission) and listed in FDA GUDID since 21 May 2019 (UDI-DI 08800022304009), active as of 21 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 21 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK221427 Date24 Aug 2022DecidedStatusActive
United StatesGUDID listing Number08800022304009 UDI-DI Date21 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221427 decided 24 Aug 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800022304009 listed 21 May 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183156
  2. Listed FDA GUDID 08800022304009
  3. Cleared FDA 510(k) K221427

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
General/multiple surgical solid-state laser system
Model / reference
V-Laser
Primary DI / UDI-DI
08800022304009
510(k) Number
FDA product code
GEX
GMDN term
General/multiple surgical solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: General/multiple surgical solid-state laser system

Similar devices in this category

Other devices filed under General/multiple surgical solid-state laser system.

Other devices from Wontech Co., Ltd

  • Oligio

    Class IIb

  • Tightan Pro

    Class IIa

  • NOUVADerm

    Class II

  • Air Gap Fiber AG365

    Class II

See all devices from Wontech Co., Ltd →

Properties

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