ESPANSIONE MARKETING SPA

FDA Device Registration & Listing · CREVALCORE Bologna, IT · Registration 3010724743

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
3010724743
FEI Number
3010724743
Entity Name
ESPANSIONE MARKETING SPA
City/State/Country
CREVALCORE Bologna, IT
Establishment Address
VIA MODIGLIANI 10, CREVALCORE Bologna 40014, IT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ESPANSIONE MARKETING SPA (Owner Number: 9098022)
Owner / Operator Contact Address
Via Degli Orefici 152, Blocco 27 Centergross, Bologna, IT-NOTA 40050 FUNO, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K124064
PMA Number
N/A

All Registered Proprietary Names

Epi-C Mask EQUINOX EPIC-C PLUS ME-CHECK ME-CHECK H IPL LAMP-20 EVOLUZIONE PLUS IPL LAMP-05 EPI-C PLUS IPL LAMP TRINITY PLUS LED MASK H-20 LED MASK H-05 LED MASK H LED MASK H-20/BLUE LED MASK H/YELLOW LED MASK H/BLUE LED MASK H-05/BLUE MASK LM YELLOW/CE-0500 IPL LAMP-LS LED MASK H-05/YELLOW IPL LAMP-DS LAMP570AC MASK LM RED/CE-0500 IPL LAMP-390 IPL LAMP-550 MASK LM BLUE/CE-0500 EPI-C PLUS/E/110V YOUNG AGAIN

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2019-12-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2007-06-22
PJZ Camera, Ophthalmic, General-Use Ophthalmic Class 2 886.1120 2018-05-17
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2010-12-18
OAP Laser, Comb, Hair Physical Medicine Class 2 890.5500 2010-12-18
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2010-12-18
OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery Class 2 878.4810 2014-01-17

Official Correspondent

Lorena Benazzi

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

ESPANSIONE MARKETING SPA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3006546131 ESPANSIONE MARKETING SPA FUNO Bologna, IT

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K881862 Thermo Body Wrap Systems, Inc. THERMO-BODY-WRAP SYSTEM 1988-10-13
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

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010724743. Last updated year: 2026. Please use registration number 3010724743 when referencing this establishment in official correspondence.
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