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
