Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
FDA 510(k) K232222 · Medency S.R.L.
510(k) numberK232222
Submission
- Device name
- Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
- Applicant
- Medency S.R.L.
Vicenza, IT - Received
- July 26, 2023
- Decision date
- November 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NVK – Laser, Dental, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.
Other 510(k)s with product code NVK
| 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 |
| 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 |
More from El.En Electronic Engineering Spa
| 510(k) | Device | Decision |
|---|---|---|
| K240543 | Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)GEX · Traditional | 10/24/2024SE |
Questions and answers
When was Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) cleared by the FDA?
Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) (K232222) received a 510(k) decision of Substantially Equivalent on November 27, 2023, 124 days after the submission was received.
What is the product code of K232222?
The FDA product code is NVK – Laser, Dental, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 878.4810.