Manufacturer
Hebei Newangie Technology Co., Ltd.Picosecond laser device (BMPS4)
Hebei Newangie 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
- K252447
- Device name
- Picosecond laser device (BMPS4)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-08-04
- Decision date
- 2025-10-01
- Submission type
- Traditional
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatmentSurgical cutting
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
Picosecond laser devices are intended for surgical and cosmetic applications in medical dermatology, general surgery 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 in 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
Picosecond laser devices are intended for surgical and cosmetic applications in medical dermatology, general surgery 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 in 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 Picosecond Laser Device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions and removal of tattoos. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). Composition of therapeutic device: main unit, light guide arm, handpiece and foot switch. The main unit includes display screen, laser, power supply, water circulation cooling system and electronic control components. Accessories include goggles, eye mask, standard hand tools, power cord, fuse tube, funnel component, drain faucet, user manual, remote control interlock connector, drain spout and keys.
Summary parsed at:2026-06-01 05:23:54 UTC
Predicate devices
3PicoSecond Nd: YAG Laser System
Picosecond Laser System (Model PS10-A and PS10-B)
Picosecond Nd:YAG Laser System; PICO LEGEND
K252447 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 K252447 as a predicate
