Manufacturer
Beijing Superlaser Technology Co., Ltd.ND:YAG Laser
Beijing Superlaser Technology 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
- K193464
- Device name
- ND:YAG Laser
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-12-16
- Decision date
- 2020-04-13
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatmentSkin resurfacing
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The ND:YAG Laser 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 Laser 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. It is for prescription use only.
Summary parsed at:2026-06-01 05:47:19 UTC
Predicate devices
2CO2 Laser Therapy Machine
ND YAG Q-switch Laser Therapy Machine
K193464 references 2 predicate/reference devices
Cited as predicate
1Q-Switched Nd: YAG Laser System (Glamor Q)
1 submission cite K193464 as a predicate