510(k) K253309 ยท NVK Laser, Dental, Soft Tissue
SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)
| Applicant | Shenzhen Soga Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, May 19, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253309
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.