NVK — Laser, Dental, Soft Tissue Class II
FDA product code NVK covers "Laser, Dental, Soft Tissue", a Class II medical device regulated under 21 CFR 878.4810. Submissions are reviewed by the General, Plastic Surgery panel. At least 17 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253309 | shenzhen soga technology co | SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers th | May 19, 2026 |
| 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 |