K214008 is an FDA 510(k) clearance for the Dental diode laser. This device is classified as a Laser, Dental, Soft Tissue (Class II - Special Controls, product code NVK).
Submitted by Shenzhen Soga Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 10, 2022, 139 days after receiving the submission on December 22, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 878.4810. Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry..
| 510(k) Number | K214008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2021 |
| Decision Date | May 10, 2022 |
| Days to Decision | 139 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NVK - Laser, Dental, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry. |