FDA.reportPublic FDA data

General/multiple surgical solid-state/carbon dioxide laser system

Definition
A mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one solid-state [e.g., neodymium-doped yttrium-aluminium-garnet (Nd:YAG)] mediated and the other carbon dixoide (CO2) mediated, intended for bloodless incisions during general surgery and/or multiple specialized surgical applications (non-dedicated). It is intended to provide both the cutting capabilities of gas mediated lasing, and the haemostatic abilities of solid-state mediated lasing. It includes a light source, delivery/positioning device(s), and controls/foot-switch. It does not include frequency doubling technology.
GUDID devices
221
Last updated
2026-06-11 06:06:16

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06970285179026Powered Laser Surgical Instrument Trixel CO2 LaserBeijing Syntech Laser Co., Ltd.CFL-102017-06-29
07290109141947FiberLase™ Robotic Drop-In Guide LUMENIS LTD.FiberLase™ Robotic Drop-In Guide 2016-08-30
07290109142036FiberLase™ Endoscope Protection SheathLUMENIS LTD.FiberLase™ Endoscope Protection Sheath2016-08-30
07290109142609OtoLase™ Straight Tip PackageLUMENIS LTD.OtoLase™ Straight Tip Package2016-10-05
07290109145051UltraScan CPGLUMENIS LTD.UltraScan CPG2021-01-13
07290109145075UltraPulse Focused Incisional HandPiece setLUMENIS LTD.UltraPulse Focused Incisional HandPiece set2021-01-13
07290109146799OtoLase™ Straight TipLUMENIS LTD.OtoLase™ Straight Tip2022-09-04
07290109146805OtoLase™ Curved TipLUMENIS LTD.OtoLase™ Curved Tip2022-09-04
08057017760252DEKA SMARTXIDE²EL.EN. SPAM103J12017-09-26
08057017760269DEKA SMARTXIDE²EL.EN. SPAM103K12017-09-26
08057017760382DEKA SmartXide² TRIO C60HEL.EN. SPAM103AE12018-11-26
08057017760399DEKA SmartXide² TRIO C80HEL.EN. SPAM103AF12018-11-26
08800017800004CYMABISON MEDICAL Co.,Ltd.CO2 laser2016-10-06
06973663790042Nd:Yag Laser Therapy SystemsBEIJING UNT TECHNOLOGY CO.,LTDNd:Yag Pro X2024-10-21
07290109146676SurgiTouch Scanner LUMENIS LTD.SurgiTouch Scanner 2022-09-22
07290109146133UltraPulse® DUOLUMENIS LTD.UltraPulse DUO2022-09-20
07290109147123AcuPulse™ 40WGLUMENIS LTD.AcuPulse™ 40WG2022-09-19
07290109147239AcuPulse™ DUOLUMENIS LTD.AcuPulse™ DUO2022-09-19
07290109147284UltraPulse™ DUOLUMENIS LTD.UltraPulse™ DUO2022-09-19
07290109147345SurgiTouch ScannerLUMENIS LTD.kit for UltraPulse/UltraPulse DUO2022-09-19
07290109146720SurgiTouch ScannerLUMENIS LTD.Upgrade kit for AcuPulse 30/40 to 30/40 ST2022-09-04
07290109147000MicroSlad™ 719 Lens Slide 200 mm LUMENIS LTD.191012022-09-04
07290109147017MicroSlad™ 719 Lens Slide 350 mmLUMENIS LTD.191042022-09-04
07290109147024MicroSlad™ 719 Lens Slide 275 mm LUMENIS LTD.191192022-09-04
07290118850014MicroSwitch JoystickLUMENIS LTD.MicroSwitch Joystick2022-09-04
07290118853237Digital AcuBlade Upgrade KitLUMENIS LTD.Digital AcuBlade Upgrade Kit2022-09-04
17290109146796OtoLase™ Straight TipLUMENIS LTD.OtoLase™ Straight Tip2022-09-04
17290109146802OtoLase™ Curved TipLUMENIS LTD.OtoLase™ Curved Tip2022-09-04
07290109146614FiberLase™ Endoscope Protection SheathLUMENIS LTD.FiberLase™ Endoscope Protection Sheath2022-07-27
07290109146003AcuPulse™ 40WGLUMENIS LTD.AcuPulse™ 40WG2022-07-25
07290109146027AcuPulse™ DUOLUMENIS LTD.AcuPulse™ DUO2022-07-25
08057017760603MultiPulse PRO 60EL.EN. SPAM110Q12021-10-20
07290109145143UltraPulse® αLUMENIS LTD.Office2021-08-02
08057017760542IMLIGHT CO2 LaserEL.EN. SPAM103AK12021-05-07
08057017760573MultiPulse PRO DUOEL.EN. SPAM110P12021-05-07
07290109144245UltraScan CPGLUMENIS LTD.UltraScan CPG2021-01-13
07290109144511UltraPulse Focused Incisional HandPiece setLUMENIS LTD.UltraPulse Focused Incisional HandPiece set2021-01-13
07290109145037UltraPulse αLUMENIS LTD.O.R.2021-01-13
07290109145044DeepFX™ Microscanner LUMENIS LTD.DeepFX™ Microscanner 2021-01-13
07290109145068TrueSpot™ 2mm HandpieceLUMENIS LTD.TrueSpot™ 2mm Handpiece2021-01-13
07290109143071FemTouch™ Standard Focus Disposable Tips LUMENIS LTD.FemTouch™ Standard Focus Disposable Tips Pack2020-12-10
07290109143323FemTouch™ Fine Focus Disposable TipsLUMENIS LTD.FemTouch™ Fine Focus Disposable Tips2020-12-10
07290109144955FemTouch™ Standard Focus TipLUMENIS LTD.FemTouch™ Standard Focus Tip2020-10-06
07290109144962FemTouch™ Adaptor kit LUMENIS LTD.FemTouch™ Adaptor kit 2020-10-06
07290109144979FemTouch™ Fine Focus TipLUMENIS LTD.FemTouch™ Fine Focus Tip2020-10-06
07290109145020AcuPulse™ WLUMENIS LTD.AcuPulse™ W2020-10-06
17290109141326Fiber InsertsLUMENIS LTD.146202016-11-15
17290109141463Fiber InsertsLUMENIS LTD.146212016-11-15
17290109142330DeepFX™ Disposable Tips LUMENIS LTD.DeepFX™ Disposable Tips2016-09-27
06970285179057Powered Laser Surgical Instrument-Trixel II CO2 LaserBeijing Syntech Laser Co., Ltd.UFL-602017-06-29
06970285179095Powered Laser Surgical Instrument-UL CO2 LaserBeijing Syntech Laser Co., Ltd.CFL-10U2017-06-29
07290109140292AcuPulse™ DUOLUMENIS LTD.AcuPulse™ DUO2016-08-22
07290109140308AcuPulse™ LUMENIS LTD.AcuPulse2016-08-15
07290109140315AcuPulse 40WGLUMENIS LTD.AcuPulse 40WG2016-08-22
07290109140322UltraPulse® DUOLUMENIS LTD.UltraPulse DUO2016-08-22
07290109140490UltraPulse® Encore™LUMENIS LTD.Office2016-08-23
07290109141039FiberLase™ HP-M 90 mm malleableLUMENIS LTD.FiberLase™ HP-M 90 mm malleable2016-08-24
07290109141046FiberLase™ HP-M 300 mm malleableLUMENIS LTD.FiberLase™ HP-M 300 mm malleable2016-08-24
07290109141053FiberLase™ HP-R 60 mm straight, curved tipLUMENIS LTD.FiberLase™ HP-R 60 mm straight, curved tip2016-08-24
07290109141060FiberLase™ HP-R 60mm straight, straight tip LUMENIS LTD.FiberLase™ HP-R 60mm straight, straight tip 2016-08-25
07290109141077FiberLase™ HP-R 140 mm straight, curved tipLUMENIS LTD.FiberLase™ HP-R 140 mm straight, curved tip2016-08-25
07290109141084FiberLase™ HP-R 180 mm straight, curved tipLUMENIS LTD.FiberLase™ HP-R 180 mm straight, curved tip2016-08-25
07290109141091FiberLase™ HP-R 180 mm straight, straight tipLUMENIS LTD.FiberLase™ HP-R 180 mm straight, straight tip2016-08-25
07290109141107FiberLase™ HP-R 240 mm bent, curved tipLUMENIS LTD.FiberLase™ HP-R 240 mm bent, curved tip2016-08-25
07290109141114FiberLase™ HP-M 140 mm malleableLUMENIS LTD.FiberLase™ HP-M 140 mm malleable2016-08-25
07290109141121FiberLase™ HP-M 240 mm malleableLUMENIS LTD.FiberLase™ HP-M 240 mm malleable2016-08-25
07290109141138FiberLase™ Handpiece Malleable Kit LUMENIS LTD.FiberLase™ Handpiece Malleable Kit 2016-08-25
07290109141145FiberLase™ HP-R 240 mm bent, straight tipLUMENIS LTD.FiberLase™ HP-R 240 mm bent, straight tip2016-08-25
07290109141152FiberLase™ HP-R 140 mm bent, straight tipLUMENIS LTD.FiberLase™ HP-R 140 mm bent, straight tip2016-08-25
07290109141169FiberLase™ Handpiece Rigid Kit LUMENIS LTD.FiberLase™ Handpiece Rigid Kit2016-08-25
07290109141176SS FiberLase™ Handpiece Rigid Kit LUMENIS LTD.SS FiberLase™ Handpiece Rigid Kit 2016-08-25
07290109141183SS FiberLase™ HP-R 60 mm straight, curved tipLUMENIS LTD.SS FiberLase™ HP-R 60 mm straight, curved tip2016-08-25
07290109141190SS FiberLase™ HP-R 60mm straight, straight tip LUMENIS LTD.SS FiberLase™ HP-R 60mm straight, straight tip 2016-08-25
07290109141206SS FiberLase™ HP-R 140 mm straight, curved tip LUMENIS LTD.SS FiberLase™ HP-R 140 mm straight, curved tip 2016-08-25
07290109141213SS FiberLase™ HP-R 140 mm bent, straight tipLUMENIS LTD.SS FiberLase™ HP-R 140 mm bent, straight tip2016-08-25
07290109141220SS FiberLase™ HP-R 180 mm straight, curved tipLUMENIS LTD.SS FiberLase™ HP-R 180 mm straight, curved tip2016-08-25
07290109141237SS FiberLase™ HP-R 180 mm straight, straight tipLUMENIS LTD.SS FiberLase™ HP-R 180 mm straight, straight tip2016-08-25
07290109141244SS FiberLase™ HP-R 240 mm bent, curved tipLUMENIS LTD.SS FiberLase™ HP-R 240 mm bent, curved tip2016-08-25
07290109141251SS FiberLase™ HP-R 240 mm bent, straight tipLUMENIS LTD.SS FiberLase™ HP-R 240 mm bent, straight tip2016-08-25
07290109141268SS FiberLase™ Handpiece-M Kit LUMENIS LTD.SS FiberLase™ Handpiece-M Kit 2016-08-25