Manufacturer
Zhengzhou PZ Laser Slim Technology Co., Ltd.Medical Picosecond ND: YAG Laser System (PZ-6)
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250041
- Device name
- Medical Picosecond ND: YAG Laser System (PZ-6)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-01-08
- Decision date
- 2025-05-14
- Submission type
- Traditional
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The Medical Picosecond ND:YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows: 1064nm wavelength: - Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue, and purple. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. 532nm wavelength: - Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow, and orange. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Intended Use
The Medical Picosecond ND:YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows: 1064nm wavelength: - Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. 532nm wavelength: - Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Device Description
The Medical Picosecond ND: YAG Laser System mainly consists of a host, a light guide arm, a treatment handle, a foot switch, a power cord, and other auxiliary treatment accessories. The host mainly includes laser power supply, laser, water circulation cooling system, control board, and display screen. The Medical Picosecond ND: YAG Laser System is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm).
Summary parsed at:2026-06-01 05:22:02 UTC
Predicate devices
3PicoSecond Nd: YAG Laser System
Picosecond Laser System (Model PS10-A and PS10-B)
Picosecond Nd:YAG Laser System; PICO LEGEND
K250041 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K250041 as a predicate
