NVK
- Product code
- NVK
- Device name
- Laser, Dental, Soft Tissue
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4810
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 17
FDA classification definition
Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253309 | 2026-05-19 | Shenzhen Soga Technology Co., Ltd. | SOGA Lasers therapy system family of Aurora handpiec | |
| K260765 | 2026-03-10 | Azena Medical, LLC | Gemini NOVA 810+980 Soft Tissue Laser | |
| K250731 | 2025-10-16 | Matelaser, Inc. | MateLaser Medical Diode Laser Systems (ML-DLS-30) | |
| K243764 | 2025-05-08 | Wuhan Pioon Technology Co., Ltd. | Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3 | |
| K230047 | 2024-03-04 | Gigaalaser Company , Ltd. | Medical Diode Laser Systems | |
| K232885 | 2024-02-28 | Shanghai Wonderful Opto-Electrics Tech | Dawn Diode Laser System | |
| K232222 | 2023-11-27 | Medency S.R.L. | Primo Dental Laser (Primo, Primo Komfort, Primo Lite |
Official FDA classification page: NVK
Classification and pathway per current FDA publications. Data from openFDA (CC0).