Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)— 510(k) K232222
Substantially EquivalentMedency S.R.L.
FDA 510(k) clearance K232222 for Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo), Substantially Equivalent on 2023-11-27. Applicant: Medency S.R.L.. Device class: 2.
Clearance details
- Applicant
- Medency S.R.L.
- Product code
- Code NVK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vicenza, IT
Recent devices under product code NVK
view all- K253309 — SOGA Lasers therapy system family of Aurora handpiece (Aurora-S) +1 more
- K260765 — Gemini NOVA 810+980 Soft Tissue Laser
- K250731 — MateLaser Medical Diode Laser Systems (ML-DLS-30)
- K243764 — Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)
- K230047 — Medical Diode Laser Systems
More clearances from Medency S.R.L.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.