FDA.reportPublic FDA data

Dermatological laser beam guiding handpiece

Definition
A hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This is a reusable device.
GUDID devices
132
Last updated
2026-09-29 04:02:12

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816722022158Pearl FractionalCUTERA, INC.Pearl Fractional2016-09-23
00816995027850Fraxel FTXSOLTA MEDICALMC-BURNPAPER-L2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALMC7MM242026-07-20
00816995027874Fraxel FTXSOLTA MEDICALMC15MM242026-07-20
00816995027904Fraxel FTXSOLTA MEDICALMCSYSFTX-LOANER2026-07-20
07290016540628Venus VelocityVENUS CONCEPT LTDVL0000012017-03-13
07290016540635Venus Velocity ApplicatorVENUS CONCEPT LTDAS1400102017-03-13
07290016540642Small light guideVENUS CONCEPT LTDAS1400162017-03-13
07290016540659Medium Light GuideVENUS CONCEPT LTDAS1400172017-03-13
07290016540666Large Light GuideVENUS CONCEPT LTDAS1400182017-03-13
07290016540673Venus Velocity kitVENUS CONCEPT LTDPK0001052017-03-13
07290016541359Venus Velocity applicator full packageVENUS CONCEPT LTDAS1400602018-11-18
06973511890177SANOBeijing Sano Lasers S&T Development Co., Ltd.SHE-LSP601-32026-06-10
00850020752492NIRA Bundle +Nira Innovations Incorporated179-0002025-11-19
06972558160038LaserconnSanhe Laserconn Tech Co., Ltd.Milestone Smart-M2022-12-13
06972558160045LaserconnSanhe Laserconn Tech Co., Ltd.Milestone Standard-A2022-12-13
05060555750756LYMA LaserLYMA LIFE LIMITED12026-01-28
05060555753412LYMA Laser PROLYMA LIFE LIMITED12026-01-28
00850020752263NIRA Bundle (Pro Gen 3, White)Nira Innovations Incorporated181-000-C012025-12-08
00850020752430NIRA Pro (Gen 3,white)Nira Innovations Incorporated180-000-C012025-12-08
00850020752447NIRA Precision LaserNira Innovations Incorporated118-000-C012025-12-08
00850020752560NIRA Pro+ (Champagne)Nira Innovations Incorporated174-000-C022025-12-08
00850020752577NIRA Pro (Gen 3,Champagne)Nira Innovations Incorporated180-000-C022025-12-08
00850020752584NIRA Bundle (Gen 2 Pro, Champagne)Nira Innovations Incorporated179-000-C022025-12-08
00850020752591NIRA Bundle (Pro Gen 3, Champagne)Nira Innovations Incorporated181-000-C022025-12-08
06971679500914NubwayBeijing Nubway S&T Co., Ltd.QNHF-012025-05-17
00816995027775Fraxel FTXSOLTA MEDICALMC15MM122025-04-02
00816995027782Fraxel FTXSOLTA MEDICALMC7MM122025-04-02
00816995027805Fraxel FTXSOLTA MEDICALMCSYSFTX2025-04-02
G7433426Smooth Beauty LaserTria Laser IncSRL2025-03-07
07898961835426handPICOVYDENCE MEDICAL263782025-01-21
00850020752454NIRA Pro+Nira Innovations Incorporated174-0002024-12-26
08056893740013STARDUST MEDINTELLIGENCE TARGET SYSTEM SRLG100.30002024-06-26
07898961835037LongPulseVYDENCE MEDICAL180852024-05-27
07898961835044ProDeepVYDENCE MEDICAL207462024-05-27
07898961835051GoSmoothVYDENCE MEDICAL180972024-05-27
07898961835068DualModeVYDENCE MEDICAL207442024-05-27
078989618352283-10/vlVYDENCE MEDICAL217992024-05-27
078989618352353-24/hrVYDENCE MEDICAL218062024-05-27
078989618352425-15/ltVYDENCE MEDICAL218032024-05-27
078989618352598-18/hrVYDENCE MEDICAL218052024-05-27
07898961835266handPICOVYDENCE MEDICAL271852024-05-27
07898961835075ACROMA-QSVYDENCE MEDICAL180982024-03-13
00817495024417CO2RE IntimaCandela CorporationAS897342023-10-20
00817495024523Intima Sterile 2 Internal + 1 External HP, Accessories KitCandela CorporationKT780112023-10-20
00817495024547Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE IntimaCandela CorporationKT778212023-10-20
00817495024554External Handpiece 5-Pack Sterile Single-Use, CO2RE IntimaCandela CorporationKT779112023-10-20
00817495025056Regular Internal Handpiece Sterile Single-Use, CO2RE IntimaCandela CorporationAS951912023-10-20
00817495025063CO2RE IntimaCandela CorporationAS952012023-10-20
07290117772188Stellar M22™ ResurFX™ ModuleLUMENIS BE LTDNA2023-08-10
07290117772201"M22 IPL ""VA"" Filter"LUMENIS BE LTDNA2023-08-10
07290117772218"M22 IPL ""AC"" Filter"LUMENIS BE LTDNA2023-08-10
07290117770191Stellar M22™ ResurFX™ Module Upgrade KitLUMENIS BE LTDNA2023-08-02
07290117770207ResurFX™ HeadLUMENIS BE LTDNA2023-08-02
07290117770436ResurFX™ SapphireCool™ TipLUMENIS BE LTDNA2023-08-02
07290117770566ResurFX™ Precision TipLUMENIS BE LTDNA2023-08-02
00850020752119NIRA PRONira Innovations Incorporated151-0002023-07-14
00850020752126NIRA Precision LaserNira Innovations Incorporated117-0002023-04-13
00816722022844Pearl FractionalCUTERA, INC.Pearl Fractional2022-11-30
07290016681437HR-MiniFORMATK SYSTEMS LTDFS800212021-06-25
07290016681444HR-MaxFORMATK SYSTEMS LTDFS800222021-06-25
00817495021522GentleYAG 12/15/18 RGD Delivery System W/DCDCandela Corporation7122-00-37922016-09-23
00817495021539GentleLase Handpiece AssemblyCandela Corporation7121-00-75902016-09-23
00817495021553GentleYAG 6/8/10MM RGD Delivery System W/DCDCandela Corporation7122-00-38362016-09-23
00817495021560GentleYAG 12/15/18MM RGD Delivery System W/O FiberCandela Corporation7122-00-85072016-09-23
00817495021577ALEX2 5MM SPOT SIZE ASSYCandela Corporation7122-00-85212016-09-23
00817495021607GentleYAG 1.5/3MM Delivery System W/DCDCandela Corporation7122-00-36342016-09-23
00817495021614GentleYAG LE 12MM RGD Delivery SystemCandela Corporation7122-00-75422016-09-23
00817495021621GentleYAG LE 8MM RGD Delivery SystemCandela Corporation7122-00-75532016-09-23
00817495021638GentleYAG LE 3MM Delivery System W/DCDCandela Corporation7122-00-36212016-09-23
00817495021645GentleYAG Delivery System W/DCDCandela Corporation0800-00-10502016-09-23
00817495021652GentleYAG HR Delivery System W/DCDCandela Corporation0800-00-10512016-09-23
00817495021669GentleYAG SR Delivery System W/DCDCandela Corporation0800-00-10522016-09-23
00817495021676GentleYAG SR Delivery System W/DCDCandela Corporation0800-00-10532016-09-23
00817495021683GentleYAG SR Delivery System W/DCDCandela Corporation0800-00-10542016-09-23
00817495021690GentleYAG SR Delivery System W/DCDCandela Corporation0800-00-10552016-09-23
00817495021706GentleYAG SR Delivery System W/DCDCandela Corporation0800-00-10562016-09-23
00817495021713GentleYAG SR Delivery System W/DCDCandela Corporation0800-00-10582016-09-23
00817495021720GYAG,HR DLVY SYS W/O DCDCandela Corporation0800-00-10592016-09-23
00817495021737GentleYAG SRT Delivery System W/O DCDCandela Corporation0800-00-10602016-09-23