Picosecond Laser System (Model PS10-A and PS10-B)

Beijing Adss Development 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

1

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K220268
Device name
Picosecond Laser System (Model PS10-A and PS10-B)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-01-31
Decision date
2022-08-23
Submission type
Traditional
Technology type
Picosecond(AI inferred)
Clinical applications
Pigment treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The Picosecond 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 Picosecond 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 Picosecond Laser System consists of a host, a treatment handpiece, a light guide system, a foot switch, power cords and accessories. The host contains a laser, a cooling device, a laser power supply, a control device (including a control device and a LCD) and a protective device. Accessories include a foot switch, a laser protective glasses, power cords, and a water filling device. The Picosecond Laser System is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce two laser wavelengths (i.e., 1064 nm and 532 nm).

Summary parsed at:2026-06-01 05:39:43 UTC

Predicate devices

1

K220268 references 1 predicate/reference device

Cited as predicate

3

3 submissions cite K220268 as a predicate