Solea
FDA 510(k) K221761 · Convergent Dental, Inc.
510(k) numberK221761
Submission
- Device name
- Solea
- Applicant
- Convergent Dental, Inc.
Needham, MA, US - Received
- June 17, 2022
- Decision date
- September 14, 2022
- 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 |
| 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 |
| 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 |
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Questions and answers
When was Solea cleared by the FDA?
Solea (K221761) received a 510(k) decision of Substantially Equivalent on September 14, 2022, 89 days after the submission was received.
What is the product code of K221761?
The FDA product code is NVK – Laser, Dental, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 878.4810.