FDA.reportPublic FDA data

Multi-modality skin surface treatment system

Definition
A mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.
GUDID devices
504
Last updated
2022-12-09 02:07:30

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816722021809xeo+CUTERA, INC.xeo+2022-11-30
00816722021816xeo+ SACUTERA, INC.xeo+ SA2022-11-30
07290016633269Diolaze XL 810 ApplicatorINMODE M.D LTDAG605985A2022-11-02
07290016633276Diolaze XL 755/810 ApplicatorINMODE M.D LTDAG605975A2022-11-02
07290016633283Diolaze XL 810/1064 ApplicatorINMODE M.D LTDAG605976A2022-11-02
07290016633290VLaze ApplicatorINMODE M.D LTDAG605988A2022-11-02
07290016633382InMode INMODE M.D LTDAG606992A2022-10-26
07290016633498Evolve SystemINMODE M.D LTDAG608081A2022-10-26
07290016633702EmPowerRF platformINMODE M.D LTDAG609933A2022-10-25
00817495020303Profound Matrix, Standard 64 Sublative iD, (100 Pulse), 10-Pk Candela CorporationFIN1002532022-10-21
00817495020310Profound Matrix, Standard 64 Sublative iD, (400 Pulse), 10-PkCandela CorporationFIN1002722022-10-21
00817495021379Profound Matrix, Standard 64 Sublative iD, (400 Pulse)Candela CorporationFIN1002732022-10-21
00817495024073Profound Matrix, Standard 64 Sublative iD, (100 Pulse)Candela CorporationFIN100271 2022-10-24
00817495023717Matrix Pro Cartridge box (pack of 7)Candela CorporationKT781612022-09-16
00817495023724Profound MatrixCandela CorporationFG718412022-09-15
00817495023731Matrix Pro Applicator, Profound MatrixCandela CorporationFG718512022-09-16
00817495023748Sublative RF Applicator, Profound MatrixCandela CorporationFG718612022-09-16
00817495023755Sublime Applicator, Profound MatrixCandela CorporationFG718712022-09-16
07290109952949Profound MatrixCandela CorporationFG718412022-09-15
07290109952956Matrix Pro Applicator, Profound MatrixCandela CorporationFG718512022-09-16
07290109952970Sublative RF Applicator, Profound MatrixCandela CorporationFG718612022-09-16
07290109952987Sublime Applicator, Profound MatrixCandela CorporationFG718712022-09-16
47290109952961Matrix Pro Cartridge box (pack of 7)Candela CorporationKT781612022-09-16
00817495023809Focal 44 Sublative iD, (200 Pulses), 10-Pack, Profound MatrixCandela CorporationKT782272022-09-26
00817495023816Focal 44 Sublative iD (200 pulses), Profound MatrixCandela CorporationAS961212022-09-26
00817495023823Standard 64 Sublative iD, (200 Pulses), 10-Pack, Profound MatrixCandela CorporationKT782262022-09-26
00817495023830Standard 64 sublative iD, (200 pulses), Profound Matrix Candela CorporationAS961222022-09-26
00817495023762Focal 44 Sublative iD (200 Pulses), 10 PackCandela CorporationKT729622022-09-20
00817495023779Focal 44 Sublative iD (200 Pulses)Candela CorporationAS793542022-09-20
00817495023786Standard 64 Sublative iD (200 Pulse), 10 PackCandela CorporationKT729312022-09-20
00817495023793Standard 64 Sublative iD (200 Pulse) Candela CorporationAS793332022-09-20
00810096330048NAFR TipsLumenis Be, Inc.NAFR Tips2022-09-13
08056389700644MY MASK-EESPANSIONE MARKETING SPAMY MASK-E/M250N2022-07-18
08056389700651MY MASK-EESPANSIONE MARKETING SPAMY MASK-E/M500N2022-07-18
08056389700668MY MASK-EESPANSIONE MARKETING SPAMY MASK-E/M2000N2022-07-18
08056389700712E-LIGHT LINEESPANSIONE MARKETING SPALAMP570AC2022-07-18
00817495023311Matrix ProCandela CorporationAS096272022-05-20
00817495023458Nordlys SystemCandela Corporation9SYS7751-2032022-05-20
08057017760566DEKA MOTUS AZ+EL.EN. SPAM130A12022-04-05
08057017760597DEKA MOTUS AZEL.EN. SPAM130B12022-04-05
06970745919001ApolomedShanghai Apolo Medical Technology Co.,LtdHS-900K2022-02-17
00817495023489Frax 1940Candela Corporation9APP79082022-02-09
07290109144726Stellar M22LUMENIS LTD.Stellar M222019-08-06
07290109144733Stellar M22 Universal IPL kitLUMENIS LTD.Stellar M22 Universal IPL kit2019-08-06
07290109144757Stellar M22 Universal IPL HeadLUMENIS LTD.Stellar M22 Universal IPL Head2019-08-06
07290109144764Stellart M22 - ResurFX UpgradeLUMENIS LTD.Stellart M22 - ResurFX Upgrade2019-08-06
07290109144795Stellar M22 515 nm filter LUMENIS LTD.Stellar M22 515 nm filter 2019-08-06
07290109144801Stellar M22 560 nm filter LUMENIS LTD.Stellar M22 560 nm filter 2019-08-06
07290109144818Stellar M22 590 nm filter LUMENIS LTD.Stellar M22 590 nm filter 2019-08-06
07290109144825Stellar M22 615 nm filter LUMENIS LTD.Stellar M22 615 nm filter 2019-08-06
07290109144832Stellar M22 640 nm filter LUMENIS LTD.Stellar M22 640 nm filter 2019-08-06
07290109144849Stellar M22 695 nm filter LUMENIS LTD.Stellar M22 695 nm filter 2019-08-06
07290109144863Stellar M22 Acne filter LUMENIS LTD.Stellar M22 Acne filter 2019-08-06
07290109144870Stellar M22 Vascular filter LUMENIS LTD.Stellar M22 Vascular filter 2019-08-06
17290110122215Tip ClearLift QS 5x5 with Depth Control Set (Female)ALMA LASERS LTD.12021-12-30
17290110122222Tip ClearLift QS 5x5 without Depth Control Set (Female)ALMA LASERS LTD.12021-12-30
17290110122239ClearLift Depth Control Set for ClearLift QS 5x5 (No Lasing Tip) Female ALMA LASERS LTD.12021-12-30
17290110122246Tip ClearLift QS CVD (Female)ALMA LASERS LTD.12021-12-30
17290110122253Tip ClearLift QS KTP 532 3mm (Female)ALMA LASERS LTD.12021-12-30
17290110122260Tip ClearLift QS KTP 532 4mm (Female)ALMA LASERS LTD.12021-12-30
17290110122277Tip ClearLift QS Scanner 5x5 & CVD (Female)ALMA LASERS LTD.12021-12-30
17290110122284Tip ClearLift QS 3mm (Female)ALMA LASERS LTD.12021-12-30
17290110122291Tip ClearLift QS 5mm (Female)ALMA LASERS LTD.12021-12-30
17290110122307Tip ClearLift QS 10mm (Female)ALMA LASERS LTD.12021-12-30
08056389700637EPI-C MASKESPANSIONE MARKETING SPAEQUINOX2021-10-04
G050OXYLIGHT0OXYLIGHTRAJA MedicalOXYLIGHT2021-09-09
07290109145303OptiLight IPL Handpiece NFLUMENIS LTD.OptiLight IPL Handpiece NF2021-09-06
00841494100230ASSY, FOCUS ARRAY, PICO300Cynosure, LLC100-7051-0572021-08-05
00841494100537ASSY, FINAL LASER, PICO300Cynosure, LLC100-7051-0102021-08-05
07290109145105OptiLight IPL HandpieceLUMENIS LTD.OptiLight IPL Handpiece2021-07-25
07290109145273OptiLight IPL Upgrade KitLUMENIS LTD.OptiLight IPL Upgrade Kit2021-07-25
07290109145280OptiLight™LUMENIS LTD.OptiLight™2021-07-25
17290110122093Hybrid System 30W 120V 50/60 HZALMA LASERS LTD.12021-07-11
17290110122109Hybrid System 70W 120V 50/60 HZ ALMA LASERS LTD.12021-07-11
17290110122116ProScan Applicator for Hybrid SystemALMA LASERS LTD.12021-07-11
17290110122123Pixel CO2 7x7 & 9x9 Applicator for Hybrid SystemALMA LASERS LTD.12021-07-11
17290110122130HyLight 50 VSS Applicator for US Hybrid SystemALMA LASERS LTD.12021-07-11
17290110122147HyLight 200 VSS Applicator for US Hybrid SystemALMA LASERS LTD.12021-07-11
07290109145198IPL Upgrade Kit for Stellar OptimaLUMENIS LTD.IPL Upgrade Kit for Stellar Optima2021-05-27
16973504240009AymoMedical Device Branch of Zhangzhou Easepal Industrial CorporationAymo Beauty D50 148Q-BD50XX-USWH0A2021-05-20