V-Laser
by Wontech Co., Ltd 3 variants
510(k) K231054
V-Laser is a Class II device made by Wontech Co., Ltd, cleared under FDA 510(k) K231054 on 14 Aug 2023, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231054 | Date14 Aug 2023 | StatusActive |
Official records
- FDA 510(k) database K231054
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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 K231054
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.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ALMA VEIL; V-Laser | ALMA VEIL; V-Laser | 08800022304016 | — | On the market |
Similar devices
Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).
- Ceralas Diode Laser System (Ceralas D15) by Ceram Optec, Inc.
- BIOSYAG 50 MED by Bios S.R.L.
- Lasersonics Ultraline III Sterile Disposable Fiber by Heraeus Surgical, Inc.
- Endocoagulator Models 8 and 20 Argon Laser by Hgm, Inc.
- Laser Laparoscopic Cholecystectomy by Surgical Laser Technologies, Inc.
- Model YC-1200/PHOTOCOAGULATOR Ophthalmic Laser by Nidek, Inc.
- Accure Laser System by Accure Acne, Inc.
- Cheveux Diode Laser System by Sandstone Medical Technologies, LLC
- CO2 Surgical Laser System by Niic U.S.A., Inc.
- Models 4000/6000/8000/8900 Laser for Derma/Surgery by Cooper Lasersonics, Inc.