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Alma Veil

by Wontech Co., Ltd

510(k) K251094

Alma Veil is a Class II device made by Wontech Co., Ltd, cleared under FDA 510(k) K251094 on 6 May 2025, active as of 22 Oct 2026.

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 NumberK251094 Date6 May 2025ClearedStatusActive

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  • Withdrawn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

Devices cleared under K251094

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 K251094
UDI-DISize and differences
ALMA VEIL; V-Laser
WONTECH CO., LTD
ALMA VEIL; V-Laser08800022304016 —On the market

Similar devices

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

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