Dawn Diode Laser System
FDA 510(k) K232885 · Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
510(k) numberK232885
Submission
- Device name
- Dawn Diode Laser System
- Applicant
- Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
Shanghai, CN - Received
- September 18, 2023
- Decision date
- February 28, 2024
- 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 |
| 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 |
|---|---|---|
| K243037 | Diode Laser System model Dawn-SGEX · Traditional | 12/26/2024SE |
| K222265 | DiosculptPKT · Traditional | 09/23/2022SE |
| K183122 | 810nm Diode Laser SystemGEX · Traditional | 08/25/2019SE |
| K163655 | SparklingGEX · Traditional | 03/17/2017SE |
| K161356 | Matrix LS-40 CO2 Laser SystemGEX · Traditional | 09/09/2016SE |
Questions and answers
When was Dawn Diode Laser System cleared by the FDA?
Dawn Diode Laser System (K232885) received a 510(k) decision of Substantially Equivalent on February 28, 2024, 163 days after the submission was received.
What is the product code of K232885?
The FDA product code is NVK – Laser, Dental, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 878.4810.