K211150 is an FDA 510(k) clearance for the Dental diode laser, SOGA Laser, ILaser II. 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 July 1, 2022, 438 days after receiving the submission on April 19, 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 | K211150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2021 |
| Decision Date | July 01, 2022 |
| Days to Decision | 438 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. |