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V-Laser

by Wontech Co., Ltd 3 variants

510(k) K221427

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK221427 Date24 Aug 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GEX
FDA applicant
Wontech Co., Ltd.
Device class
Class II
Regulation
21 CFR Part 878.4810
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The V-Laser is a laser device classified under the product code GEX, intended for use in general and plastic surgery procedures. It delivers controlled laser energy for tissue treatment, including vascular and pigment-related applications, as supported by its FDA 510(k) clearance under the Special review pathway.

This device is supplied by Wontech Co., Ltd. and is intended for single-use or reusable applications in clinical settings, with regulatory clearance granted in the United States. Its specifications align with the Substantially Equivalent (SESE) determination by the FDA’s Skin and Soft Tissue (SU) advisory committee. No additional sterility, MRI safety, or size details are provided in the available data.

Devices cleared under K221427

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K221427
UDI-DISize and differences
V-Laser
WONTECH CO., LTD
V-Laser08800022304009 —On the market

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Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

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