Manufacturer
Beijing Adss Development Co., Ltd.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
Product code
GEX
21 CFR 878.4810
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
2Cited as predicate
4ND:YAG Laser
ProFlex CO2 Laser Fiber
MEDIYAG
Q-Switched Nd:Yag laser
4 submissions cite K161926 as a predicate
