FDA.reportPublic FDA data

LUTRONIC CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30044835383004483538LUTRONIC CORPORATION1N2026-01-01219, Sowon-Ro Deogyang-gu Goyang-si Gyeonggi KR 10534
30062477123006247712Lutronic Aesthetics, Inc.1Y2026-01-013/5 Carlisle Road Westford MA US 01886
30137895083013789508Lutronic Corporation1N2026-01-01Poskom Tower, 3F, 227, Sowon-ro Deogyang-gu Goyang-si Gyeonggi KR 10534
30237064043023706404Lutronic Corporation1N2026-01-0156 Cheombok-ro, Dong-gu Daegu Gyeongbuk KR 41069

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08809447650883INFINI - INFINI MFR G U110V (INFINI Radiofrequency System)215-205-2219jvojir@lutronic.com
08809447650982N/A - INFINI MFR Handpiece (MFR Handpiece)215-205-2219jvojir@lutronic.com
08809447651019N/A - INFINI Handpiece cradle stand assy (Handpiece cradle)215-205-2219jvojir@lutronic.com
08809447651675N/A - Healite II 830&590nm Head (830/590nm head)215-205-2219jvojir@lutronic.com
08809447651699Healite II - Healite Body Assy(System Main Body)215-205-2219jvojir@lutronic.com
08809447651729N/A - Healite II Arm(Arn)215-205-2219jvojir@lutronic.com
08809447651781N/A - INFINI MFR TIP A-49 1 ea(MFR 49 Tip)215-205-2219jvojir@lutronic.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
780321621633196K251327XERFGEI2025-08-11
2251451621633196K251327XERFGEI2025-08-11
780322006112268K244060eCO2 3DONG2025-07-31
2251452006112268K244060eCO2 3DONG2025-07-31
2251451198632767K233550MOSAIC 3D (Surgical Laser)ONG2024-01-02
2251451365033622K213569HOLLYWOOD SPECTRA Laser SystemGEX2022-02-04
2251451763119205K203788DermaV Laser SystemGEX2021-03-26
2251451069138346K192331LaseMD LEO Laser SystemGEX2019-11-12
780261069138346K192331LaseMD LEO Laser SystemGEX2019-11-12
2251451589060173K183566CLARITY II Laser SystemGEX2019-06-14
780261589060173K183566CLARITY II Laser SystemGEX2019-06-14
780261452102474K180945LUTRONIC GENIUS Radiofrequency SystemGEI2018-12-10
2251451452102474K180945LUTRONIC GENIUS Radiofrequency SystemGEI2018-12-10
3083611452102474K180945LUTRONIC GENIUS Radiofrequency SystemGEI2018-12-10
2251451020266738K173700PICOPLUS Laser SystemGEX2018-06-19
780261020266738K173700PICOPLUS Laser SystemGEX2018-06-19
2251451737168973K171009LASEMD Laser SystemGEX2017-06-23
780261737168973K171009LASEMD Laser SystemGEX2017-06-23
2251451532224634K163196ACTION II Laser SystemGEX2017-05-24
780261532224634K163196ACTION II Laser SystemGEX2017-05-24
2251451534575051K153769R:GEN Laser SystemHQF2016-10-05
780261534575051K153769R:GEN Laser SystemHQF2016-10-05
2251451850034021K141555ADVANTAGEGEX2014-11-06
780261850034021K141555ADVANTAGEGEX2014-11-06
2251451839421422K130199CLARITY LPC LASER SYSTEMGEX2013-11-22
780261839421422K130199CLARITY LPC LASER SYSTEMGEX2013-11-22
3083611966646979K121481INFINI RADIOFREQUENCY SYSTEMGEI2013-06-25
780261966646979K121481INFINI RADIOFREQUENCY SYSTEMGEI2013-06-25
2251451966646979K121481INFINI RADIOFREQUENCY SYSTEMGEI2013-06-25
2251451686493859K113668HEALITE II SYSTEMILY2012-06-19
3083611686493859K113668HEALITE II SYSTEMILY2012-06-19
780261686493859K113668HEALITE II SYSTEMILY2012-06-19
2251451221203522K113588SPECTRA LASER SYSTEMGEX2012-02-22
780261221203522K113588SPECTRA LASER SYSTEMGEX2012-02-22
2251451100583031K100610LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMSONG2011-01-20
780261100583031K100610LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMSONG2011-01-20
2251451504365561K091320SPECTRA SP II, SPECTRA DENTA IIGEX2009-08-19
780261504365561K091320SPECTRA SP II, SPECTRA DENTA IIGEX2009-08-19
780261683679657K070392MOSAIC LASER SYSTEMGEX2007-07-13
780261000800403K050254SPECTRA-SP CO2 LASER SYSTEMGEX2005-04-15
780261808120509K032735SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEMGEX2003-12-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX282022-02-04
GEI112025-08-11
ONG72025-07-31
ILY42012-06-19
HQF22016-10-05

PMN#

R:GEN

2022-12-27

Lutronic Vision, Inc.

GUDID#

200 records. Showing 1-40. Next