Panels › General, Plastic Surgery › Product code NVK · Class 2
Laser, Dental, Soft Tissue
Regulation 878.4810
2510(k)s in 12 months (17 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in NVK
| Company | 510(k)s | Recalls |
|---|---|---|
| Shenzhen Soga Technology Co., Ltd. | 3 | 0 |
| Azena Medical, LLC | 2 | 0 |
| Convergent Dental, Inc. | 1 | 1 |
| El.En Electronic Engineering Spa | 2 | 0 |
| Biolase, Inc. | 1 | 0 |
| Dentlight, Inc. | 1 | 0 |
| Gigaalaser Company , Ltd. | 1 | 0 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | 1 | 0 |
| Kavo America | 1 | 0 |
| Matelaser, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 19, 2026 | K253309 | SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode Shenzhen Soga Technology Co., Ltd., CN | NVK |
| Mar 10, 2026 | K260765 | Gemini NOVA 810+980 Soft Tissue Laser Azena Medical, LLC | NVK |
| Oct 16, 2025 | K250731 | MateLaser Medical Diode Laser Systems (ML-DLS-30) Matelaser, Inc. | NVK |
| May 8, 2025 | K243764 | Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) Wuhan Pioon Technology Co., Ltd., CN | NVK |
| Mar 4, 2024 | K230047 | Medical Diode Laser Systems Gigaalaser Company , Ltd., CN | NVK |
| Feb 28, 2024 | K232885 | Dawn Diode Laser System Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd, CN | NVK |
| Nov 27, 2023 | K232222 | Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) Medency S.R.L., IT | NVK |
| Sep 14, 2022 | K221761 | Solea Convergent Dental, Inc. | NVK |
| Jul 1, 2022 | K211150 | Dental diode laser, SOGA Laser, ILaser II Shenzhen Soga Technology Co., Ltd., CN | NVK |
| May 10, 2022 | K214008 | Dental diode laser Shenzhen Soga Technology Co., Ltd., CN | NVK |
| Mar 11, 2022 | K213658 | DEKA SMARTPERIO El.En Electronic Engineering Spa | NVK |
| Mar 10, 2022 | K210367 | D-Laser Blue, D-Laser 16 Guilin Woodpecker Medical Instrument Co., Ltd., CN | NVK |
| Dec 22, 2021 | K213428 | EdgePro Biolase, Inc. | NVK |
| Nov 18, 2021 | K210350 | Gemini 2 810+980 Soft Tissue Laser Azena Medical, LLC | NVK |
| Aug 23, 2021 | K203396 | DEKA SMARTPERIO El.En Electronic Engineering Spa, IT | NVK |
| Feb 26, 2021 | K201387 | Ultrafast, Ultrafast Plus, Ultrafast Lite Dentlight, Inc. | NVK |
| Aug 3, 2005 | K030146 | KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ Kavo America | NVK |
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