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Data / Medical devices / Italy / Quanta System, S.P.A.

Quanta System, S.P.A.: FDA-registered device maker in SAMARATE Varese, Italy, 36 510(k) clearances

Quanta System, S.P.A. is registered with the FDA (registration 3004378299) in SAMARATE Varese, Italy. It lists 6 device types. The FDA files 36 510(k) clearances under its listings, the newest dated June 6, 2025. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Quanta System, S.P.A.
FDA registration number
3004378299
Address
Via Acquedotto, 109, SAMARATE Varese, Italy, 21017
Owner or operator
QUANTA SYSTEM, S.P.A. (9057522)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
March 4, 2011
Registered through
2027
Brand names listed
585, ASSET, Accure, CYBER TM 150, CYBER TM 200, Chrome, Cryo6, CryoMini and more

Devices it lists

DeviceProduct codeClassRoleSource
Cart, Emergency, Cardiopulmonary (Excluding Equipment)BZN1Exporter to the USaccessdata.fda.gov
Extractor, Vacuum, FetalHDB2Exporter to the USaccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Exporter to the USaccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)BTA2Exporter to the USaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 6, 2025K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
February 19, 2025K243588Single Use CO2 Laser Fiber (HAF005001)GEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
October 10, 2024K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
September 3, 2024K242251Litho 60; Litho 100; Litho 150GEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
October 20, 2023K232236EchoGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
January 20, 2023K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
March 16, 2022K220426Fiber Dust PROGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
February 2, 2022K211228RossoGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
March 11, 2021K210142Fiber DustGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
November 18, 2020K202503ChromeGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
October 15, 2020K202041Opera EvoGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
July 31, 2020K192499Cyber BladeGCJSubstantially EquivalentSIDAM S.r.l.accessdata.fda.gov
February 25, 2020K200234Surgical laser fibersGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
December 20, 2019K192990Litho EvoGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
September 17, 2019K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
September 6, 2019K192160EVO PlatformGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
October 17, 2018K182669Youlaser CO2GEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
September 17, 2018K181632Venacure 1470 ProGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
May 8, 2018K180922Empower H100, Cyber Ho 100, Litho 100GEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
March 16, 2018K180426Empower H35GEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
March 15, 2018K180423Empower H65GEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
February 14, 2018K180158Surgical Laser fibersGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
December 13, 2017K1730022940 nm Er:Yag Laser HandpieceGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
October 17, 2017K172198585GEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
July 7, 2017K171711Thunder, Thunder VT, Thunder HRGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
December 1, 2016K163009LithoGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
March 18, 2016K160513Quanta System Surgical Laser fibersGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
August 8, 2014K141101LITHOGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
August 7, 2014K141403LITHO DK30GEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
October 24, 2013K131473(QUANTA SYSTEM) SURGICAL LASER FIBERSGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
October 11, 2013K130123BASIC AND DOMINANT FLEX SUCTION PUMPSBTASubstantially EquivalentMedela AGaccessdata.fda.gov
July 3, 2013K131081CYBER TM FAMILYGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
January 20, 2011K103539QUANTA SYSTEM DUOLITEGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
April 4, 2008K080735CRYOMINIGEXSubstantially EquivalentZimmer Elektromedizin GmbHaccessdata.fda.gov
February 24, 2006K060395CRYO, MODEL V6.0GEXSubstantially EquivalentZimmer Elektromedizin GmbHaccessdata.fda.gov
May 31, 1995K952006ACCU-BEAM FIBER OPTIC HANDPIECEGEXSubstantially EquivalentTti Medicalaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 27, 202187814Class IITerminatedOlympus Sterile Optical Laser Fiber, single use and reusableProduct sterility is potentially compromised.accessdata.fda.gov
November 7, 201264039Class IITerminatedQ-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for generaQuanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.accessdata.fda.gov

Compare with other makers

Updated June 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.