Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004378299

FEI Number

3004378299

Entity Name

QUANTA SYSTEM, S.P.A.

City/State/Country

SAMARATE Varese, IT

Establishment Address

VIA ACQUEDOTTO, 109, SAMARATE Varese 21017, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

QUANTA SYSTEM, S.P.A. (Owner Number: 9057522)

Owner / Operator Contact Address

via Acquedotto 109, --, Samarate, IT-VA 21017, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191842

PMA Number

N/A

All Registered Proprietary Names

Olympus Empower H100 Suprema 4V Suprema VT Domino Suprema Duetto Suprema Suprema VT+ Surgical Tray 71/4FOQS Fiber Dust PRO Thunder HR Thunder Thunder VT OptiScan TH Echo Cyber Blade Chrome Disposable Specimen Cup Litho CYBER TM 200 CYBER TM 150 OAF005501 OAF002011 OAF009911 OAF008011 OAF005511 OAF008001 OAF002711 OAF009901 OAF003611 OAF003601 OAF006001 OAF006011 OAF002001 OAF002701 OAF402011 OAF703691 OAF703611 OAF702791 OAF402711 OAF702701 OAF702711 OAF703601 OAF302711 OAF302721 OAF102791 OAF103611 OAF102711 OAF103691 Twain 2940 OAF002703 OAF006003 OAF002003 OAF003603 OAF005513 OAF402013 OAF702793 OAF006013 OAF008013 OAF002013 OAF402713 OAF703603 OAF009913 OAF002713 OAF702703 OAF005503 OAF003613 OAF008003 OAF009903 OAF702713 OAF703693 OAF703612 OAF002712 OAF702712 OAF009912 OAF402712 OAF002012 OAF005512 OAF008012 OAF402012 OAF102793 OAF102713 OAF103613 OAF103693 OAF703613 Discovery Pico Derm Discovery Pico Discovery Pico Plus EMP-FBX365HS EMP-FBX200BHS EMP-FBX200HS EMP-FBX1000HS EMP-FBX272HR-C EMP-FBX550HS EMP-FBX200BHS-C EMP-FBX272HR EMP-FBX272HS-C EMP-FBX550HR EMP-FBX1000HR EMP-FBX200HR EMP-FBX272HS EMP-FBX365HR Light A Twain IPL MDK 3 Q-PLUS R Q-Plus C LIGHT A Star LIGHT 4V Q-PLUS A LIGHT B DOMINO MDK 1 MDK 2 LIGHT C Duality Litho Evo Single Use CO2 Laser Fiber Opera Evo Youlaser PRIME Youlaser PRIME MT Youlaser PRIME CO2 Litho 150 Litho 60 Litho 100 Rosso Olympus Empower H35 Cryo6 LITHO DK30 Venacure 1470 Pro STUDIO ASSET Fiber Dust Olympus Empower H65 OptiScan Youlaser Co2 LITHO Nanostar Y Nanostar C Nanostar R

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	2018-05-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-02-10
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-03-08
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-04-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2017-07-25
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-06-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-12-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-12-01
HDB	Extractor, Vacuum, Fetal	Obstetrics/Gynecology	Class 2	884.4340	2022-03-31
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2022-03-31
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2016-12-16
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-11-29
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-11-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-01-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2016-04-11
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-06-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-02-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-09-18
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-01-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-01-22
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-11-24
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-09-25
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-09-11
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-02-22
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-03-19
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-04-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-10-16
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-10-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2011-03-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-03-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-03-19
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-01-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-10-16
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-09-18

Official Correspondent

Dario Bandiera

US Agent Details

Stephen Lieberman Email: lieberman@donawa.com Phone: (561) 3020777

Related Public Records

Same Entity

QUANTA SYSTEM, S.P.A.

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, PASLT Fiber Delivery SystemSterileNon-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-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004378299. Last updated year: 2026. Please use registration number 3004378299 when referencing this establishment in official correspondence.