K210350 is an FDA 510(k) clearance for the Gemini 2 810+980 Soft Tissue Laser. This device is classified as a Laser, Dental, Soft Tissue (Class II - Special Controls, product code NVK).
Submitted by Azena Medical, LLC (Walnut Creek, US). The FDA issued a Cleared decision on November 18, 2021, 283 days after receiving the submission on February 8, 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 | K210350 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2021 |
| Decision Date | November 18, 2021 |
| Days to Decision | 283 days |
| Submission Type | Traditional |
| 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. |