Manufacturer
Hebei JT Medical Co., Ltd.Nd: YAG Laser Therapy System (QN-1)
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250722
- Device name
- Nd: YAG Laser Therapy System (QN-1)
- Company
- Hebei JT Medical Co., Ltd.
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-03-10
- Decision date
- 2025-06-06
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatmentAcne treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The Nd: YAG Laser Therapy System 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 Therapy System 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 Laser Therapy System (Model: QN-1) is a laser system which delivers laser at a wavelength 1064nm or 532nm and the pulse mode is single pulse. In the laser handpiece, there is one optical cavity containing the Nd:YAG crystal. The laser beam is directed to the treatment zone. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.
Summary parsed at:2026-06-01 05:22:32 UTC
Predicate devices
1Q-Switched Nd:Yag laser
K250722 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K250722 as a predicate