EL.EN. ELECTRONIC ENGINEERING SPA

FDA Device Registration & Listing · CALENZANO Firenze, IT · Registration 3001431138

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3001431138
FEI Number
3001431138
Entity Name
EL.EN. ELECTRONIC ENGINEERING SPA
City/State/Country
CALENZANO Firenze, IT
Establishment Address
17 VIA BALDANZESE, CALENZANO Firenze 50041, IT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
EL.EN. ELECTRONIC ENGINEERING SPA (Owner Number: 9057711)
Owner / Operator Contact Address
VIA BALDANZESE 17, --, CALENZANO, IT-FI 50041, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K240497
PMA Number
N/A

All Registered Proprietary Names

Burian Pro DEKA SMARTXIDE ULTRASPEED DEKA LUXEA PLUS Cynosure Smartskin + body ESTIQ DEKA Smart US20D DEKA SMARTXIDE2 PHYSIQ 360 OLO LUVO PHYSIQ Thermaeye Plus TORO DEKA SYNCHRO REPLAY EXCELLIUM HP DEKA SYNCHRO REPLAY EXCELLIUM 3.4 DEKA SYNCHRO REPLAY PREMIUM 1.4.2 Cynosure SLT II Cynosure Smartlipo Triplex Elite iQ PRISMA DEKA SMARTPERIO DEKA SMARTXIDE TOUCH DEKA SMARTXIDE PUNTO DEKA SMARTXIDE TETRA SMARTXIDE TOUCH HEMERA DEKA SmartXide with DOT scanner DEKA SmartXide50 with DOT scanner MOTUS AZ+ MOTUS AZ SMARTLIPO DEKA SMARTLIPO DEKA LipoAI DEKA SMARTXIDE² DEKA SMARTXIDE TOUCH MONA LISA TOUCH LILY PRISMA EMS Smartxide UltraSpeed2 PHYSIQ BioStimul handpiece DEKa Synchro Repla:Y Excellium HP DEKA Synchro Repla:Y Premium 1.4.2 DEKA Synchro Repla:Y Excellium 3.4 Cynosure Cellulaze - SLT II ONDA PRO SIMON PHYSIQ 360 EMS Elite iQ Pro Echolaser X4 DEKA HELIX DEKA SmartXide DEKA Smart US20D SMARTXIDE PRO SCAR 3 SCAR 3 PRO ERISE laser handpiece SMARTXIDE TETRA PRO

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-04-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-02-26
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2020-01-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-01-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2014-07-18
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2021-10-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2009-02-23
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-02-27
PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use General, Plastic Surgery Class 2 878.5400 2023-10-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-08-26
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-04-15
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2020-11-26
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2020-11-26
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2009-08-31
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-07-26
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2015-05-21
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2010-05-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-03-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-02-28
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2025-02-28
NVK Laser, Dental, Soft Tissue General, Plastic Surgery Class 2 878.4810 2021-08-30
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-08-30
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-02-26
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-01-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-07-13
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-12-22
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-10-25
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2014-09-09
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2024-07-26
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-02-26
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2020-01-07
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2014-02-14
OYW Laser, Cellulite Appearance General, Plastic Surgery Class 2 878.4810 2012-03-02
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2026-04-14
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2023-09-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-03-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-11-14
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output General, Plastic Surgery Class 2 878.4810 2023-01-13
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-01-13
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2007-12-28
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-03-22
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-06-05
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-04-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-04-04

Official Correspondent

PAOLO PERUZZI

US Agent Details

Greg Swanson Business: Emergo Global Consulting LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

EL.EN. ELECTRONIC ENGINEERING SPA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001431138. Last updated year: 2026. Please use registration number 3001431138 when referencing this establishment in official correspondence.
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