FDA.reportPublic FDA data

510(k) K232222

Device
Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
Applicant
Medency S.R.L.
510(k) number
K232222
Product code
NVK
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-27
Date received
2023-07-26
Regulation
878.4810
Classification name
Laser, Dental, Soft Tissue
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alessandro Zorgati
Address
Via Degli Ontani, 48 Vicenza IT 36100 36100

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NVK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)Shenzhen Soga Technology Co., Ltd.2026-05-19
K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC2026-03-10
K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.2025-10-16
K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.2025-05-08
K230047Medical Diode Laser SystemsGigaalaser Company , Ltd.2024-03-04
K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd2024-02-28
K221761SoleaConvergent Dental, Inc.2022-09-14
K211150Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd.2022-07-01
K214008Dental diode laserShenzhen Soga Technology Co., Ltd.2022-05-10
K213658DEKA SMARTPERIOEl.En Electronic Engineering Spa2022-03-11
K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.2022-03-10
K213428EdgeProBiolase, Inc.2021-12-22
K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC2021-11-18
K203396DEKA SMARTPERIOEl.En Electronic Engineering Spa2021-08-23
K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.2021-02-26