510(k) K210350
K210350 is an FDA 510(k) premarket notification submitted by Azena Medical, LLC for the device "Gemini 2 810+980 Soft Tissue Laser". The FDA issued a decision of Substantially Equivalent on November 18, 2021. The device falls under product code NVK (Laser, Dental, Soft Tissue), a Class II device regulated under 21 CFR 878.4810. Azena Medical, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2021
- Date Received
- February 8, 2021
- Clearance Type
- Traditional
- 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.