Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)
FDA 510(k) K243764 · Wuhan Pioon Technology Co., Ltd.
510(k) numberK243764
Submission
- Device name
- Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)
- Applicant
- Wuhan Pioon Technology Co., Ltd.
Wuhan, CN - Received
- December 6, 2024
- Decision date
- May 8, 2025
- 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 |
| 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 |
More from El.En Electronic Engineering Spa
| 510(k) | Device | Decision |
|---|---|---|
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)GEX · Traditional | 09/10/2026SE |
| K250656 | Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)GEX · Special | 04/04/2025SE |
| K240747 | Medical Diode Laser (M2-GK)GEX · Traditional | 06/17/2024SE |
| K240644 | Medical Diode Laser (S1Pro)GEX · Traditional | 06/10/2024SE |
| K240179 | Medical Diode Laser (Model: L2)GEX · Traditional | 03/21/2024SE |
| K231548 | Medical Diode Laser, Model S1ProGEX · Traditional | 08/03/2023SE |
| K230274 | Medical Diode Laser (M2)GEX · Traditional | 03/31/2023SE |
Questions and answers
When was Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) cleared by the FDA?
Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) (K243764) received a 510(k) decision of Substantially Equivalent on May 8, 2025, 153 days after the submission was received.
What is the product code of K243764?
The FDA product code is NVK – Laser, Dental, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 878.4810.