FDA.reportPublic FDA data

Intense pulsed light skin surface treatment system

Definition
A mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 400 - 1200nm [intense pulsed light (IPL)] for heat ablation of pigmented skin cells (selective photothermolysis) to treat multiple skin/pigmentation conditions. The device typically enables variation of treatment parameters (wavelength, duration of impulses, single/multiple impulses) for treatment of conditions such as acne, telangiectasia, pigmentation (freckles, sun spots, liver spots) and/or for hair reduction. It consists of a control unit with user interface display and control panel, and a wire-connected applicator.
GUDID devices
92
Last updated
2026-10-04 01:47:37

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06970453310022MONALIZABeijing Sincoheren S&T Development Co.,Ltd.SMQ-NYC2026-09-24
06970453310039MONALIZABeijing Sincoheren S&T Development Co.,Ltd.SMQ-NK2026-09-24
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.530 Filter2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.530(S) Filter2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.530(D) Filter2026-07-16
08800020110305SMOOTHCOOL FilterJeisys Medical Inc.545(V) Filter2026-07-16
08800020110329SMOOTHCOOL FilterJeisys Medical Inc.560 Filter2026-07-16
08800020110336SMOOTHCOOL FilterJeisys Medical Inc.590 Filter2026-07-16
08800020110343SMOOTHCOOL FilterJeisys Medical Inc.640 Filter2026-07-16
08800020110350SMOOTHCOOL FilterJeisys Medical Inc.700 Filter2026-07-16
08800020110367SMOOTHCOOL FilterJeisys Medical Inc.800 Filter2026-07-16
08800020110503SMOOTHCOOL HandpieceJeisys Medical Inc.700nm(S) Handpiece2026-07-16
08800020110510SMOOTHCOOL HandpieceJeisys Medical Inc.700nm(L) Handpiece2026-07-16
08800020110527SMOOTHCOOL HandpieceJeisys Medical Inc.560nm(S) Handpiece2026-07-16
08800020110664SMOOTHCOOL HandpieceJeisys Medical Inc.420nm(S) Handpiece2026-07-16
08800020110848SMOOTHCOOL FilterJeisys Medical Inc.420 Filter2026-07-16
08800020110855SMOOTHCOOL FilterJeisys Medical Inc.500 Filter2026-07-16
08800020106018SmoothCool HRJeisys Medical Inc.SmoothCool HR2016-11-03
00074590512175Remington ProductsSPECTRUM BRANDS, INC.IPL6000USA2016-09-30
00074590512182Remington ProductsSPECTRUM BRANDS, INC.SP6000SB2016-09-30
00074590530407Remington ProductsSPECTRUM BRANDS, INC.IPL6000Q2016-09-30
00074590533316Remington ProductsSPECTRUM BRANDS, INC.SP6000Q2016-09-30
00074590535471RemingtonSPECTRUM BRANDS, INC.IPL2000USA2019-09-26
00074590540345Luma RxSPECTRUM BRANDS, INC.IPL6800USA2016-09-30
00074590542370Luma RxSPECTRUM BRANDS, INC.SP6800SB2016-09-30
00074590542929RemingtonSPECTRUM BRANDS, INC.SP2000HR2019-09-25
00074590542974Remington ProductsSPECTRUM BRANDS, INC.IPL6000Q-R2016-09-30
00074590543131Luma RxSPECTRUM BRANDS, INC.IPL6800R2016-09-30
00074590543865Luma RxSPECTRUM BRANDS, INC.SP6800BC2016-09-30
00074590543872Luma RxSPECTRUM BRANDS, INC.SP6800FC2016-09-30
00074590544268Remington ProductsSPECTRUM BRANDS, INC.IPL6500QFB2016-09-30
00074590546033RemingtonSPECTRUM BRANDS, INC.IPL2500USA2019-09-26
00074590547894RemingtonSPECTRUM BRANDS, INC.SP7SB2019-09-26
00074590552560RemingtonSPECTRUM BRANDS, INC.IPL70002019-09-26
00852547004498VitalcontrolBEURER NORTH AMERICA, L.P.IPL100 (Art.-No. 575.40)2017-03-13
00852547004733BeurerBEURER NORTH AMERICA, L.P.IPL7500 (Art.-No. 575.71)2017-06-12
06970453270258Intensity Pulsed Light Therapy SystemBeijing ADSS Development Co., Ltd.VE20002025-10-30
06970453270265Intensity Pulsed Light Therapy SystemBeijing ADSS Development Co., Ltd.VE2000 Pro2025-10-30
06970453270272Intensity Pulsed Light Therapy SystemBeijing ADSS Development Co., Ltd.VE2000 Pro0012025-10-30
06970453270289Intensity Pulsed Light Therapy SystemBeijing ADSS Development Co., Ltd.VE2000 Pro0022025-10-30
06970453270296Intensity Pulsed Light Therapy SystemBeijing ADSS Development Co., Ltd.VE2000 PRO0032025-10-30
06976855557508Omni LaserShanghai Omni Laser Skinology Co., Ltd.KDT7502024-01-01
06979922960010MICOWEYMicowey Medical Equipment (Guangxi) Co., LTDMMABM-12026-04-08
08800020102737SmoothCool HRJeisys Medical Inc.SmoothCool HR2022-10-06
08800020103017SmoothCoolJeisys Medical Inc.SmoothCool2016-10-05
07290016746044V-IPL HP BasicVIORA LTDVTL430002016-09-23
07290016746051V-IPL HP FullVIORA LTDVTL430402016-09-23
07290016746068V-IPL HP FullVIORA LTDVTL430602016-09-23
06975617994025MULTIFUNCTIONAL SERIESBEIJING HONKON TECHNOLOGIES CO., LTD.IPL2026-03-23
00860015460622NextGen Aesthetics IPLT AESTHETICS LLCVE20002026-03-12
00860009525146MediLightMEDICREATIONS LLC2.02026-02-11
M709THCLR01TheraClearStrata Skin Sciences, Inc.TC402025-03-06
06974851083014BVLASERNanjing Bestview Laser S&T Co.,Ltd.LK-PT2024-11-27
06928258000891GSDShenzhen GSD Tech Co., Ltd.GP666C42024-09-30
06977620360019ZHEONEHebei Zhemai Technology Co., Ltd. FI-L062024-09-19
06974223650042Planar LED mate Shenzhen Leaflife Technology Co., Ltd.LH-LNIRS2024-09-09
0880970938041110PLTENTECH Inc.10PL-Body2024-06-28
0880970938043510PLTENTECH Inc.10PL-H/P2024-06-28
00850062978003WORLD AESTHETIX BROAD PULSED LIGHTWORLD AESTHETIX LLCWAX1612862024-06-25
16976855557505Omni LaserShanghai Omni Laser Skinology Co., Ltd.KDT7502024-01-01
06973698659758JOVS IPL Hair Removal DeviceShenzhen Qianyu Technology Co., LtdJR82023-09-18
06976404770211ONEBEAUTYGlan Electronics Co.,Ltd.OBT-022023-05-31
06973512860056HuameiShandong Huamei Technology Co.,Ltd.EROSE-YA2023-05-09
06973512860063HuameiShandong Huamei Technology Co.,Ltd.EROSE-YB62023-05-09
06975526410005BENIONEShenzhen Noble Smart Manufacturing Tech. Co., Ltd.M052W11012023-01-10
06974223650028Leaf lifeShenzhen Leaflife Technology Co., Ltd.LH-LIPLB2022-11-03
06973512860032HuameiShandong Huamei Technology Co.,Ltd.HM-IPL-J12022-10-21
06973512860049HuameiShandong Huamei Technology Co.,Ltd.HM-IPL-J22022-10-21
08800020102720SmoothCool HRJeisys Medical Inc.SmoothCool HR2022-10-06
06973698652018JOVS Graphene Hair Removal DeviceShenzhen Qianyu Technology Co., LtdJOC-910-Yellow2022-09-08
06973698652339JOVS Hair Removal DeviceShenzhen Qianyu Technology Co., LtdJR5C-E2022-09-08
06973698659109JOVS Hair Removal DeviceShenzhen Qianyu Technology Co., LtdJR5C-W2022-09-08
06973698659116JOVS Hair Removal DeviceShenzhen Qianyu Technology Co., LtdJR5C-OG2022-09-08
06973698659772JOVS Hair Removal DeviceShenzhen Qianyu Technology Co., LtdJR5-E2022-09-08
06970453270043Ipl Therapy MachineBeijing ADSS Development Co., Ltd.VE20002018-04-09
06973494935001GlobaliplBEIJING GLOBALIPL DEVELOPMENT CO., LTD.US5002022-08-16
06973698650823JOVS Hair Removal DeviceShenzhen Qianyu Technology Co., LtdJR5C-E2022-07-31
06973698650830JOVS Hair Removal DeviceShenzhen Qianyu Technology Co., LtdJR5C-W2022-07-31
06973698650854JOVS Hair Removal DeviceShenzhen Qianyu Technology Co., LtdJR5C-OG2022-07-31
06973698652230JOVS Hair Removal DeviceShenzhen Qianyu Technology Co., LtdJR5-W2022-07-31