NVK — Laser, Dental, Soft Tissue Class II
Classification Details
- Product Code
- NVK
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- DE
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260765 | azena medical | Gemini NOVA 810+980 Soft Tissue Laser | March 10, 2026 |
| K250731 | matelaser | MateLaser Medical Diode Laser Systems (ML-DLS-30) | October 16, 2025 |
| K243764 | wuhan pioon technology co | Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) | May 8, 2025 |
| K230047 | gigaalaser company | Medical Diode Laser Systems | March 4, 2024 |
| K232885 | shanghai wonderful opto-electrics tech.co | Dawn Diode Laser System | February 28, 2024 |
| K232222 | medency | Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Trip | November 27, 2023 |
| K221761 | convergent dental | Solea | September 14, 2022 |
| K211150 | shenzhen soga technology co | Dental diode laser, SOGA Laser, ILaser II | July 1, 2022 |
| K214008 | shenzhen soga technology co | Dental diode laser | May 10, 2022 |
| K213658 | el.en electronic engineering | DEKA SMARTPERIO | March 11, 2022 |
| K210367 | guilin woodpecker medical instrument co | D-Laser Blue, D-Laser 16 | March 10, 2022 |
| K213428 | biolase | EdgePro | December 22, 2021 |
| K210350 | azena medical | Gemini 2 810+980 Soft Tissue Laser | November 18, 2021 |
| K203396 | el.en electronic engineering | DEKA SMARTPERIO | August 23, 2021 |
| K201387 | dentlight | Ultrafast, Ultrafast Plus, Ultrafast Lite | February 26, 2021 |
| K030146 | kavo america | KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ | August 3, 2005 |