FDA.reportPublic FDA data

510(k) K203396

Device
DEKA SMARTPERIO
Applicant
El.En Electronic Engineering Spa
510(k) number
K203396
Product code
NVK
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-23
Date received
2020-11-18
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
Paolo Peruzzi
Address
Via Baldanzese, 17 Calenzano IT 50041 50041

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
K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.2023-11-27
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
K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.2021-02-26