510(k) K232222
K232222 is an FDA 510(k) premarket notification submitted by Medency S.R.L. for the device "Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)". The FDA issued a decision of Substantially Equivalent on November 27, 2023. The device falls under product code NVK (Laser, Dental, Soft Tissue), a Class II device regulated under 21 CFR 878.4810. Medency S.R.L. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 2023
- Date Received
- July 26, 2023
- 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.