FDA.reportPublic FDA data

Dermatological carbon dioxide laser system

Definition
A mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam, intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, scar treatment, skin tightening, and lesion/hair/tattoo removal. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch.
GUDID devices
149
Last updated
2026-10-04 01:47:37

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06970453310084MONALIZABeijing Sincoheren S&T Development Co.,Ltd.Monaliza-52026-09-24
06973011720080CO2 Laser Therapy SystemSanhe LEFIS Electronics Co., LtdLFS-D9U2026-08-07
08800020109576FootswitchJeisys Medical Inc.HRF-M82026-07-16
08800020109613FootswitchJeisys Medical Inc.971-SWNO2102026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.Edge Fractional Handpiece2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.Edge Surgical Handpiece F1002026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.Edge Surgical Handpiece F502026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.120S Tip2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.120 Tip2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.350 Tip2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.800 Tip2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.Surgical Tip2026-07-16
08800291821801eCO2 DENTACynosure Lutronic Technology CorporationeCO2 DENTA_220V2026-06-25
00851842007197LightScalpelLightscalpel, LLCLS-20102016-09-24
00851842007623LightScalpelLightscalpel, LLCLS-40202023-06-26
00841494100506Affirm 10mm TipCynosure, LLC100-7004-9102016-09-24
00841494100513Affirm, 14mm TipCynosure, LLC100-7004-8142016-09-24
00894338002726FELS Laser SystemOMNIGUIDE, INC.FELS-25A2016-09-22
06970453270326Fractional CO2 Laser Therapy SystemBeijing ADSS Development Co., Ltd.FG900-S2025-10-30
06970453270333Fractional CO2 Laser Therapy SystemBeijing ADSS Development Co., Ltd.FG900-S22025-10-30
07290109952376Hand Piece Internal hygienic, Packaged, CO2RESYNERON MEDICAL LTDAS897332017-03-09
07290109952383Handpiece external hygienic Packaged CO2RESYNERON MEDICAL LTDAS902452017-03-09
07290109952390Hygienic Hand Piece Internal, Packaged, CO2RE Intima SYNERON MEDICAL LTDAS89733US2016-11-27
07290109952406Hygienic Hand Piece, external, Packaged, CO2RE Intima SYNERON MEDICAL LTDAS90245US2016-11-27
08033945934798Youlaser CO2QUANTA SYSTEM SPAPGMS000072016-08-18
08056477090008LASERING SRLLASERING SRLSLIM EVOLUTION2016-09-13
08056477090015LASERING SRLLASERING SRLSLIM EVOLUTION II2016-09-13
08057017760078DEKA SMARTXIDEEL.EN. SPAM079R12016-09-13
08057017760085DEKA SMARTXIDE 50EL.EN. SPAM079AL12016-09-13
08057017760092DEKA SMART US-20DEL.EN. SPAM079B12016-09-13
08057017760139SMARTSKIN+EL.EN. SPAM079AZ12016-09-13
08057017760146DEKA SMARTXIDE²EL.EN. SPAM103P12016-09-13
08057017760153DEKA SMARTXIDE TOUCHEL.EN. SPAM110C12016-09-13
08059173390021Youlaser CO2QUANTA SYSTEM SPAPGMS000132019-01-07
08800020104014Edge Jeisys Medical Inc.Edge 2016-11-03
08800020104021Edge ArmJeisys Medical Inc.Edge Arm2016-11-03
08800020110015Edge ONEJeisys Medical Inc.Edge ONE2016-11-18
08800020110022Edge ONE ArmJeisys Medical Inc.Edge ONE Arm2016-11-18
08800023200034Fraxis Duo Scanner H/PILOODA.CO.,LTDFRX 2.0 Scanner H/P2016-12-16
08800291821160eCO2 3DCynosure Lutronic Technology CorporationScanner HP2026-04-15
08800291821177eCO2 3DCynosure Lutronic Technology CorporationRoller Tip2026-04-15
08800291821184eCO2 3DCynosure Lutronic Technology CorporationStatic Tip 1202026-04-15
08800291821191eCO2 3DCynosure Lutronic Technology CorporationStatic Tip 3002026-04-15
08800291821207eCO2 3DCynosure Lutronic Technology CorporationStatic Tip 5002026-04-15
08800291821214eCO2 3DCynosure Lutronic Technology CorporationScanner Tip Set2026-04-15
08800291821221eCO2 3DCynosure Lutronic Technology CorporationScanner Tip Set(only static tip)2026-04-15
08800291821238eCO2 3DCynosure Lutronic Technology CorporationF100 handpiece2026-04-15
08800291821245eCO2 3DCynosure Lutronic Technology CorporationF100 connector2026-04-15
08800291821252eCO2 3DCynosure Lutronic Technology CorporationF100 connector_D2026-04-15
08800291821269eCO2 3DCynosure Lutronic Technology CorporationF100 normal tip2026-04-15
08800291821276eCO2 3DCynosure Lutronic Technology CorporationF50 handpiece2026-04-15
08800291821283eCO2 3DCynosure Lutronic Technology CorporationF50 Normal tip2026-04-15
08800291821290eCO2 3DCynosure Lutronic Technology CorporationF50 Normal Tip_D2026-04-15
08800291821306eCO2 3DCynosure Lutronic Technology CorporationZoom handpiece2026-04-15
08800291821313eCO2 3DCynosure Lutronic Technology CorporationZoom connector2026-04-15
08800291821320eCO2 3DCynosure Lutronic Technology CorporationZoom connector_D2026-04-15
08800291821337eCO2 3DCynosure Lutronic Technology CorporationeCO2 3D 110V2026-04-15
08809447651583eCO2Lutronic CorporationeCO2 PLUS(USA) body2016-09-09
08809447651606N/ALutronic CorporationeCO2 PLUS(USA) ARM2016-09-09
08809578390009FRACTIONAL CO2 LASERIDS LtdSMAXEL2018-12-31
06975617993011CO2 FRACTIONAL LASERBEIJING HONKON TECHNOLOGIES CO., LTD.106002026-03-23
06974077940023MLKJWeifang Mingliang Electronics Co., Ltd.EXFU CO22025-09-17
06973511890108SANOBeijing Sano Lasers S&T Development Co., Ltd.SHE-LSP003-12025-02-10
08800016903683Secret PRO Set PackageCLASSYS Inc.FRX-C22024-10-31
08800016903690Secret PRO Main UnitCLASSYS Inc.FRX-C22024-10-31
08800016903706Secret PRO Articulated ArmCLASSYS Inc.FRX-C22024-10-31
08800016903713Secret PRO Scanner HandpieceCLASSYS Inc.FRX-C22024-10-31
08800016903720Secret PRO Needle HanpdieceCLASSYS Inc.FRX-C22024-10-31
08800016903737Secret PRO Bigger HandpieceCLASSYS Inc.FRX-C22024-10-31
08800016903744Secret PRO Smartcure HandpieceCLASSYS Inc.FRX-C22024-10-31
08800016903621Fraxis DUO Set PackageCLASSYS Inc.FRX-C22024-10-30
08800016903638Fraxis Duo Main UnitCLASSYS Inc.FRX-C22024-10-30
08800016903645Fraxis Duo Articulated armCLASSYS Inc.FRX-C22024-10-30
08800016903652Fraxis Duo Scanner HandpieceCLASSYS Inc.FRX-C22024-10-30
08800016903959Fraxis Set PackageCLASSYS Inc.FRX-C12024-10-30
08800016903966Fraxis Main UnitCLASSYS Inc.FRX-C12024-10-30
08800016903973Fraxis HandpieceCLASSYS Inc.FRX-C12024-10-30
08800016903980Fraxis Zoom HandpieceCLASSYS Inc.FRX-C12024-10-30
06928258000884GSDShenzhen GSD Tech Co., Ltd.GP900F2024-09-30
08034108512709DEKA SMARTXIDE PRODEKA M.E.L.A. SRLM079BI12024-04-09