FDA.reportPublic FDA data

Multi-modality skin surface treatment system

Definition
An electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] 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 energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.
GUDID devices
246
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841494100360ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300Cynosure, LLC100-7051-0682021-08-05
00841494100582Focal Guide 6 x 6Cynosure, LLC5520-20272016-09-24
00841494100599Focal Guide 10 x 10Cynosure, LLC5520-20242016-09-24
00841494103514MaxG 4mm AdapterCynosure, LLC2520-00272016-09-24
00841494103576MaxYs 4mm AdapterCynosure, LLC2520-00452016-09-24
00850055552074InBella RF SystemInbella Medical IncNG604881D2026-03-26
00850055552302InBellaIgnite SystemInbella Medical IncNG613237D2026-03-26
00850055552364InBella Multi System (InBellaEmPower)Inbella Medical IncNG604881D2026-03-31
00850055552470InBellaBody SystemInbella Medical IncNG609899D2026-03-25
00850055552494BellaTform ApplicatorInbella Medical IncNG609899D2026-04-02
00850055552555InBellaMax SystemInbella Medical IncNG613190D2026-03-25
00850055552630Bella515 Black ApplicatorInbella Medical IncNG613075D2026-04-02
00850055552647Bella580 Black ApplicatorInbella Medical IncNG613077D2026-04-02
00850055552654BellaVlaze Black ApplicatorInbella Medical IncNG613079D2026-04-02
00850055552661BellaXL 755/810 Black ApplicatorInbella Medical IncNG613088D2026-04-02
00850055552678BellaXL 810/1064 Black ApplicatorInbella Medical IncNG613089D2026-04-02
00850055552685BellaXL 810 Black ApplicatorInbella Medical IncNG613090D2026-04-02
00860010841181Zemits QuidionAdvance-Esthetic LLC12025-10-26
00860013757557Zemits DioPulseAdvance-Esthetic LLC12025-10-26
00863249000350Joule Diva SystemSCITON, INC.Joule Diva System2026-04-24
05713530000314EllipseEllipse A/SYdun2018-09-18
05713530000420EllipseEllipse A/SNordlys2019-08-05
05713530000468EllipseEllipse A/SYdun2019-08-05
06973504240002AymoMedical Device Branch of Zhangzhou Easepal Industrial CorporationAymo Beauty D50 148Q-BD50XX-USWH0A2021-05-20
06973504240019AymoMedical Device Branch of Zhangzhou Easepal Industrial CorporationAymo Beauty D50 148Q-BD50XX-USDG0A2021-05-20
07290016746402V-FR HandpieceVIORA LTDV-FR20022026-04-19
07290016746457V-ST Single Use tipVIORA LTDAS470002025-06-03
07290016746501V-FR TipVIORA LTDVTO20022026-04-19
07290016746662V-FC TipVIORA LTDVTL480142025-05-22
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPALED MASK H2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPALED MASKH-052019-09-03
08056389700101E-LIGHT LINEESPANSIONE MARKETING SPAEPI-C PLUS/E/110V2018-06-06
08056389700125E-LIGHT LINEESPANSIONE MARKETING SPAIPL LAMP2018-06-06
08056389700149E-LIGHT LINEESPANSIONE MARKETING SPAIPL LAMP-052018-06-06
08056389700163E-LIGHT LINEESPANSIONE MARKETING SPAIPL LAMP-202018-06-06
08056389700200E-LIGHT LINEESPANSIONE MARKETING SPALED MASK/YELLOW-052018-06-06
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAEPI-C PLUS2026-04-30
08057017760108DEKA SYNCHRO REPLA:Y EXCELLIUM 3.4EL.EN. SPAM104K12016-09-13
08057017760115DEKA SYNCHRO REPLA:Y EXCELLIUM HPEL.EN. SPAM104L12016-09-13
08057017760122DEKA SYNCHRO REPLA:Y PREMIUM 1.4.2EL.EN. SPAM104J12016-09-13
08057017760344DEKA MOTUS AYEL.EN. SPAM115B12019-03-15
10810096330045NAFR TipsLumenis Be, Inc.NAFR Tips2022-09-13
10885380009020CARDINAL HEALTHCardinal Health 200, LLCCF-10012016-09-08
17290117770631Q-Switched Nd:YAG Disposable Tips Spot size 2mmLUMENIS BE LTDQ-Switched Nd:YAG Disposable Tips Spot size 2mm2023-08-02
17290117770648Q-Switched Nd:YAG Disposable Tips Spot size 2.5mmLUMENIS BE LTDQ-Switched Nd:YAG Disposable Tips Spot size 2.5mm2023-08-02
17290117770655Q-Switched Nd:YAG Disposable Tips Spot size 3.5mmLUMENIS BE LTDQ-Switched Nd:YAG Disposable Tips Spot size 3.5mm2023-08-02
17290117770662Q-Switched Nd:YAG Disposable Tips Spot size 5mmLUMENIS BE LTDQ-Switched Nd:YAG Disposable Tips Spot size 5mm2023-08-02
07290110123772Handpiece LP Nd:Yag 1064 Cooled for Harmony XL Pro (color cooled gray)ALMA LASERS LTD.12026-03-02
07898786930030ZYE-ULTRA FDAVYDENCE MEDICAL313032026-02-18
07898786930047ONE FDAVYDENCE MEDICAL313042026-02-18
08057017760979EXIRAEL.EN. SPAM126AC12026-02-16
00860009525108MediSpaMEDICREATIONS LLC1.02026-02-11
07290016746563V-IPL Optic set Full 6 filtersVIORA LTDVTL43050-62025-12-22
07290117772737Multi-Spot™ Nd:YAG HeadLUMENIS BE LTDNA2025-12-21
07290117772744M22™ Q-Switched HeadLUMENIS BE LTDNA2025-12-21
07290117772751Stellar M22™ Multi-Spot™ Nd:YAG Upgrade kitLUMENIS BE LTDNA2025-12-21
07290117772768Stellar M22™ Q-Switched Nd:YAG Upgrade KitLUMENIS BE LTDNA2025-12-21
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLM117B12025-12-16
08436560853169ToskaniTOSKANI SL.NF2025-12-12
G050DOXYLIGHTIONIX0OXYLIGHTRAJA MedicalD OXYLIGHT IONIX2025-09-24
07290110123888CO2 LiteScan Applicator FOR INCALMA LASERS LTD.12025-09-21
05391540830826Préime DermaFacialEMA AESTHETICS LIMITEDAquaB2025-09-15
05391540830833Préime DermaFacialEMA AESTHETICS LIMITEDVibroX2025-09-15
05391540830871Préime DermaFacial EMA AESTHETICS LIMITEDConsole2025-09-15
07290117772645Black Stellar XPL HPLUMENIS BE LTDNA2025-09-08
07290117772652Stellar XPL Module KitLUMENIS BE LTDNA2025-09-08
07290016746785V-FC Pro FullVIORA LTDVTL48015-F2025-09-01
07290016746808V-FC Pro TipVIORA LTDVTL480182025-09-01
07290016746815V-FC Pro HandpieceVIORA LTDVTL480172025-09-01
17290016746652V-FC TipVIORA LTDAS700282025-05-22
07290019863267Luxora SystemINMODE M.D LTDAG613237A2025-08-11
07290110123741Alma Pixel 30W 120V 50/60Hz Black (Inc)ALMA LASERS LTD.12025-08-11
05391540830840Préime DermaFacialEMA AESTHETICS LIMITEDMicroT2025-08-07
05391540830857Préime DermaFacial EMA AESTHETICS LIMITEDCollagen+2025-08-07
07290110123680Pixel CO2 30W 120V 50/60Hz Black (Inc)ALMA LASERS LTD.12025-07-08
07290016746464V-ST Single Use tipVIORA LTDAS470002025-06-03
07290016746471V-VR HandpieceVIORA LTDVTL480102025-06-03
00860012651009CytoPeelEMAGE MEDICAL LLCCP32025-05-22
00860012651016CytoPen NGEMAGE MEDICAL LLCCNG2025-05-22
00860012651023Cyto-RFEMAGE MEDICAL LLCCRF2025-05-22