FDA product code NVK: Laser, Dental, Soft Tissue
NVK is the FDA product code for laser, dental, soft tissue. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the Dental panel. FDA has cleared 17 510(k) submissions under NVK, 12 in the last five years, from 13 different applicants. The average 510(k) review took 254 days (median 219); 198 days on average over the last three years. FDA has posted 2 recalls for NVK devices, 1 initiated in the last five years.
Definition
Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.
Classification
| Field | Value |
|---|---|
| Device name | Laser, Dental, Soft Tissue |
| Device class | Class II |
| Regulation | 21 CFR 878.4810 |
| Review panel | DE — Dental |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NVK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 4 | 224 |
| 2022 | 5 | 235 |
| 2023 | 1 | 124 |
| 2024 | 2 | 293 |
| 2025 | 2 | 186 |
| 2026 | 2 | 116 |
Compare with all 510(k) review times · Search every NVK clearance
Top NVK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shenzhen Soga Technology Co., Ltd. | 3 | 2026-05-19 |
| Azena Medical, LLC | 2 | 2026-03-10 |
| El.En Electronic Engineering Spa | 2 | 2022-03-11 |
| Matelaser, Inc. | 1 | 2025-10-16 |
| Wuhan Pioon Technology Co., Ltd. | 1 | 2025-05-08 |
8 more applicants have NVK clearances. See the full list in Caduvo.
Most recent NVK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253309 | Shenzhen Soga Technology Co., Ltd. | SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) | 2026-05-19 | 232 |
| K260765 | Azena Medical, LLC | Gemini NOVA 810+980 Soft Tissue Laser | 2026-03-10 | 1 |
| K250731 | Matelaser, Inc. | MateLaser Medical Diode Laser Systems (ML-DLS-30) | 2025-10-16 | 219 |
| K243764 | Wuhan Pioon Technology Co., Ltd. | Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) | 2025-05-08 | 153 |
| K230047 | Gigaalaser Company , Ltd. | Medical Diode Laser Systems | 2024-03-04 | 423 |
Recalls for NVK devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-09-01.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code NVK?
NVK is the FDA product code for laser, dental, soft tissue. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the Dental panel.
What device class is NVK?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code NVK?
Across 17 cleared submissions the average was 254 days from receipt to decision (median 219).
Which companies have the most NVK clearances?
Shenzhen Soga Technology Co., Ltd. (3); Azena Medical, LLC (2); El.En Electronic Engineering Spa (2); Matelaser, Inc. (1); Wuhan Pioon Technology Co., Ltd. (1).
Have NVK devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-09-01.
Next steps
- Run an FDA pathway report with predicate devices for product code NVK
- Run a recall and safety report across every NVK manufacturer
- Watch product code NVK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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