FDA.reportPublic FDA data

QUANTA SYSTEM, S.P.A.

Matched from indexed company URL: Quanta System, S.p.A

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30043782993004378299QUANTA SYSTEM, S.P.A.1N2026-01-01VIA ACQUEDOTTO, 109 SAMARATE Varese IT 21017

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1964141689303625K952006ACCU-BEAM FIBER OPTIC HANDPIECEGEX1995-05-31
1964141325020738K243588Single Use CO2 Laser Fiber (HAF005001)GEX2025-02-19
1964141529286943K242251Litho 60; Litho 100; Litho 150GEX2024-09-03
1964141371379123K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTGEX2024-10-10
1964141940169910K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermGEX2025-06-06
1964141016868794K232236EchoGEX2023-10-20
1964141493506228K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VGEX2023-01-20
1964141821920132K220426Fiber Dust PROGEX2022-03-16
1964141272050810K211228RossoGEX2022-02-02
1964141755072398K210142Fiber DustGEX2021-03-11
1964141320050859K202503ChromeGEX2020-11-18
1964141458431071K202041Opera EvoGEX2020-10-15
1964141306955772K200234Surgical laser fibersGEX2020-02-25
1964141223140844K192990Litho EvoGEX2019-12-20
1964141773021717K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60GEX2020-02-21
1964141110178823K192499Cyber BladeGCJ2020-07-31
1964141361775954K192160EVO PlatformGEX2019-09-06
1964141774017283K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermGEX2019-09-17
1964142051016335K182669Youlaser CO2GEX2018-10-17
1964141311674401K181632Venacure 1470 ProGEX2018-09-17
1964142028859273K180922Empower H100, Cyber Ho 100, Litho 100GEX2018-05-08
1964141866326048K180426Empower H35GEX2018-03-16
1964141026656328K180423Empower H65GEX2018-03-15
1964141983411027K180158Surgical Laser fibersGEX2018-02-14
1964141088371741K1730022940 nm Er:Yag Laser HandpieceGEX2017-12-13
1964142002376351K172198585GEX2017-10-17
1964141876881186K172025Litho 60GEX2017-07-31
1964141779725830K171711Thunder, Thunder VT, Thunder HRGEX2017-07-07
1964141087610699K170366Laser Peripherals, LLC Family of Bare Laser FibersGEX2017-06-08
1964141401766373K163009LithoGEX2016-12-01
1964141304894576K160513Quanta System Surgical Laser fibersGEX2016-03-18
1964141934913612K152714Quanta ForteGEX2015-12-21
1964141829819165K152220MH01GEX2015-09-03
1964141537575147K151629Guardian 1000GEX2015-10-27
1964141855959714K141403LITHO DK30GEX2014-08-07
1964142054109386K141101LITHOGEX2014-08-08
1964141229269545K131473(QUANTA SYSTEM) SURGICAL LASER FIBERSGEX2013-10-24
1964141231195355K131081CYBER TM FAMILYGEX2013-07-03
1964141107469896K130444H-30 HOLMIUM LASER SYSTEMGEX2013-05-22
1964141098593154K130123BASIC AND DOMINANT FLEX SUCTION PUMPSBTA2013-10-11
1964141141966353K124003MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBEGEX2013-01-17
1964141725797298K103539QUANTA SYSTEM DUOLITEGEX2011-01-20
1964141039799965K080735CRYOMINIGEX2008-04-04
1964141544584242K060395CRYO, MODEL V6.0GEX2006-02-24
1964141169261769K051113QUANTA SYSTEM ETRNA GIOVINEZZAGEX2006-01-04
1964141759583510
1964141916510595
1964141985934789

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX432025-06-06
GCJ12020-07-31
BTA12013-10-11

PMN#

Echo

2023-10-20

Quanta System Spa

Rosso

2022-02-02

Quanta System SpA

Chrome

2020-11-18

Quanta System Spa

Litho

2016-12-01

Quanta System SpA

MH01

2015-09-03

QUANTA SYSTEM SPA

LITHO

2014-08-08

QUANTA SYSTEM, S.P.A.

51 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next