Laser, Dental, Soft Tissue
FDA product code NVK · Class II (moderate risk) · 21 CFR 878.4810 · General, Plastic Surgery
Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.
17510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Shenzhen Soga Technology Co., Ltd. 3
- El.En Electronic Engineering Spa 2
- Azena Medical, LLC 2
- Kavo America 1
- Dentlight, Inc. 1
- Biolase, Inc. 1
- Guilin Woodpecker Medical Instrument Co., Ltd. 1
- Convergent Dental, Inc. 1
- Medency S.R.L. 1
- Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd 1
- Gigaalaser Company , Ltd. 1
- Wuhan Pioon Technology Co., Ltd. 1
- Matelaser, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253309 | SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…NVK · Traditional | Shenzhen Soga Technology Co., Ltd. | 05/19/2026SE |
| K260765 | Gemini NOVA 810+980 Soft Tissue LaserNVK · Traditional | Azena Medical, LLC | 03/10/2026SE |
| K250731 | MateLaser Medical Diode Laser Systems (ML-DLS-30)NVK · Traditional | Matelaser, Inc. | 10/16/2025SE |
| K243764 | Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)NVK · Traditional | Wuhan Pioon Technology Co., Ltd. | 05/08/2025SE |
| K230047 | Medical Diode Laser SystemsNVK · Traditional | Gigaalaser Company , Ltd. | 03/04/2024SE |
| K232885 | Dawn Diode Laser SystemNVK · Traditional | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 02/28/2024SE |
| K232222 | Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)NVK · Traditional | Medency S.R.L. | 11/27/2023SE |
| K221761 | SoleaNVK · Traditional | Convergent Dental, Inc. | 09/14/2022SE |
| K211150 | Dental diode laser, SOGA Laser, ILaser IINVK · Abbreviated | Shenzhen Soga Technology Co., Ltd. | 07/01/2022SE |
| K214008 | Dental diode laserNVK · Abbreviated | Shenzhen Soga Technology Co., Ltd. | 05/10/2022SE |
| K213658 | Deka SmartperioNVK · Special | El.En Electronic Engineering Spa | 03/11/2022SE |
| K210367 | D-Laser Blue, D-Laser 16NVK · Traditional | Guilin Woodpecker Medical Instrument Co., Ltd. | 03/10/2022SE |
| K213428 | EdgeProNVK · Special | Biolase, Inc. | 12/22/2021SE |
| K210350 | Gemini 2 810+980 Soft Tissue LaserNVK · Traditional | Azena Medical, LLC | 11/18/2021SE |
| K203396 | Deka SmartperioNVK · Traditional | El.En Electronic Engineering Spa | 08/23/2021SE |
| K201387 | Ultrafast, Ultrafast Plus, Ultrafast LiteNVK · Traditional | Dentlight, Inc. | 02/26/2021SE |
| K030146 | Kavo Key Laser 1242 and Kavo Key Laser 1243+NVK · Traditional | Kavo America | 08/03/2005SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0324-2024 Class II | Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with…It has been found that potential unintended laser activation can occur without foot pedal depression. | Convergent Dental | 09/01/2023Open, Classified |
| Z-0587-2010 | SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase…The SoftLase Lasers are in need of compliance upgrades due to lack of a remote interlock connector, an… | Zap Lasers LLC | 08/08/2008Terminated |