ND YAG Q-switch Laser Therapy Machine

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

2

Cited as predicate

4

Device details

FDA 510(k) registration fields

K number
K161926
Device name
ND YAG Q-switch Laser Therapy Machine
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-07-13
Decision date
2017-02-22
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Pigment treatmentVascular treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The ND YAG Q-switch Laser Therapy Machine is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.

Intended Use

The ND YAG Q-switch Laser Therapy Machine is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.

Device Description

The ND YAG Q-switch Laser Therapy Machine is a laser system which delivers laser at a wavelength of 1064nm or 532nm. There are 3 models included, FG 2010, FG 2010-B, FG 2010-C, the three models have the same intended use, mechanism of action, principle and specification, only differences are the configurations. The detailed difference shown as following: Model FG2010 (Size: 860×310×830mm, Weight: 60kg), FG2010-B (Size: 800×320×920mm, Weight: 65kg), FG2010-C (Size: 830×320×830mm, Weight: 60kg). Main components include the main unit, articulated arm for holding of Treatment Probe, Treatment Probe for laser delivery, and Foot Pedal to control pulse light output.

Summary parsed at:2026-06-01 05:58:47 UTC

Predicate devices

2

K161926 references 2 predicate/reference devices

Cited as predicate

4

4 submissions cite K161926 as a predicate