510(k) K211150
K211150 is an FDA 510(k) premarket notification submitted by Shenzhen Soga Technology Co., Ltd. for the device "Dental diode laser, SOGA Laser, ILaser II". The FDA issued a decision of Substantially Equivalent on July 1, 2022. The device falls under product code NVK (Laser, Dental, Soft Tissue), a Class II device regulated under 21 CFR 878.4810. Shenzhen Soga Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2022
- Date Received
- April 19, 2021
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Dental, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- DE
- Submission Type
Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.