FDA Product Code
FDA Product Code NVK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253309 | SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) | Shenzhen Soga Technology Co., Ltd. | 2026-05-19 | Traditional | PDF ↗ |
| K260765 | Gemini NOVA 810+980 Soft Tissue Laser | Azena Medical, LLC | 2026-03-10 | Traditional | PDF ↗ |
| K250731 | MateLaser Medical Diode Laser Systems (ML-DLS-30) | Matelaser, Inc. | 2025-10-16 | Traditional | PDF ↗ |
| K243764 | Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) | Wuhan Pioon Technology Co., Ltd. | 2025-05-08 | Traditional | PDF ↗ |
| K230047 | Medical Diode Laser Systems | Gigaalaser Company , Ltd. | 2024-03-04 | Traditional | PDF ↗ |
| K232885 | Dawn Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2024-02-28 | Traditional | PDF ↗ |
| K232222 | Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) | Medency S.R.L. | 2023-11-27 | Traditional | PDF ↗ |
| K221761 | Solea | Convergent Dental, Inc. | 2022-09-14 | Traditional | PDF ↗ |
| K211150 | Dental diode laser, SOGA Laser, ILaser II | Shenzhen Soga Technology Co., Ltd. | 2022-07-01 | Abbreviated | PDF ↗ |
| K214008 | Dental diode laser | Shenzhen Soga Technology Co., Ltd. | 2022-05-10 | Abbreviated | PDF ↗ |
| K213658 | DEKA SMARTPERIO | El.En Electronic Engineering Spa | 2022-03-11 | Special | PDF ↗ |
| K210367 | D-Laser Blue, D-Laser 16 | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-03-10 | Traditional | PDF ↗ |
| K213428 | EdgePro | Biolase, Inc. | 2021-12-22 | Special | PDF ↗ |
| K210350 | Gemini 2 810+980 Soft Tissue Laser | Azena Medical, LLC | 2021-11-18 | Traditional | PDF ↗ |
| K203396 | DEKA SMARTPERIO | El.En Electronic Engineering Spa | 2021-08-23 | Traditional | PDF ↗ |
| K201387 | Ultrafast, Ultrafast Plus, Ultrafast Lite | Dentlight, Inc. | 2021-02-26 | Traditional | PDF ↗ |
| K030146 | KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ | Kavo America | 2005-08-03 | Traditional | PDF ↗ |
Product code NVK · Class II · General, Plastic Surgery. Data: openFDA.