Picosecond laser device (BMPS4)

Hebei Newangie Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

3

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

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