Manufacturer
Wontech Co., Ltd.V-Laser
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K183156
- Device name
- V-Laser
- Company
- Wontech Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-11-15
- Decision date
- 2019-04-24
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Surgical cuttingSkin tightening
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The V-Laser laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
Intended Use
The V-Laser laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
Device Description
The V-Laser is a Nd:YAG laser operating at wavelengths of 1,064 nm and 532 nm. The V-Laser consists of the main body, optical fiber cable, user-undetachable laser handpiece, handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered to the skin through the optical fiber terminated by the handpiece. The fluence (energy density), frequency and pulse are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.
Summary parsed at:2026-06-01 05:54:50 UTC
Predicate devices
1Family of CoolGlide Aesthetic Lasers
K183156 references 1 predicate/reference device
Cited as predicate
1V-Laser
1 submission cite K183156 as a predicate