Device details
FDA 510(k) registration fields
- K number
- K260375
- Device name
- Nd: YAG Laser Therapy Systems
- Company
- Sanhe Meditech Co., Ltd.
- Country / region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2026-02-05
- Decision date
- 2026-03-31
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatmentSurgical cutting
- Primary application
- Pigment treatment
- Classification source
- AI classified
