FDA.reportPublic FDA data

Laser skin surface treatment system applicator

Definition
A handpiece that is part of a skin surface treatment system that conducts one or more generated laser-based energies (e.g., Er:YAG lasers; Er:Glass lasers, long-pulsed Nd:YAG laser, and Q-switched Nd:YAG laser) used 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 device is connected to a generator and is applied by a practitioner or staff directly to the area to be treated. This is a reusable device.
GUDID devices
167
Last updated
2020-12-16 09:18:12

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08033945938321Twain 2940 EvoQUANTA SYSTEM SPAOAM0020292018-03-30
00816995027461CLEAR+BRILLIANT TOUCHSOLTA MEDICALCBT-CONSOLE-R2020-09-01
00816995027478CLEAR+BRILLIANT TOUCHSOLTA MEDICALCBT-HP-1440-R2020-09-01
00816995027485CLEAR+BRILLIANT TOUCHSOLTA MEDICALCBT-HP-1927-R2020-09-01
00817495027210FSE, PicoWay 785nm HandpieceCandela Corporation7123-57-01912019-12-12
00817495022864PicoWay 532nm Resolve Fusion HandpieceCandela Corporation7123-00-05362019-12-12
00817495022871Kit, PicoWay 730nm HandpieceCandela Corporation7123-00-05902019-12-12
00817495022888Kit, PicoWay 1064nm Resolve HPCandela Corporation7123-00-05912019-12-12
00817495022895Kit, PicoWay 532nm Resolve HPCandela Corporation7123-00-05922019-12-12
00817495022901Kit, PicoWay 532 HE Resolve HPCandela Corporation7123-00-05932019-12-12
00817495022925Kit, PicoWay 532nm Resolve Fusion HPCandela Corporation7123-00-05952019-12-12
00817495023007VBeam Prima CC Delivery SystemCandela Corporation7123-00-04312019-12-12
00817495023014VBeam Prima DCD Delivery SystemCandela Corporation7123-00-04332019-12-12
00817495023106PicoWay Zoom Handpiece KitCandela Corporation7123-00-06372020-01-03
08174950227212FSE, PicoWay 785nm HandpieceCANDELA CORPORATION7123-57-01912019-12-12
06971679500020Q Switched Nd:YAG Laser machineBeijing Nubway S&T Co., Ltd.QLHF-022020-07-23
00816995027263FRAXELSOLTA MEDICALMC-SYS-SR1500-D-INTL2020-07-13
00816995027270FRAXELSOLTA MEDICALMC-RS-CRTL-INTL2020-07-13
00816995027287FRAXELSOLTA MEDICALMC-F2-INTL-RT1L2020-07-13
00816995027294FRAXELSOLTA MEDICALMC-F2-INTL-RT1ES2020-07-13
00816995027300CLEAR+BRILLIANT TOUCHSOLTA MEDICALCBT-CONSOLE2020-07-13
00816995027317CLEAR+BRILLIANT TOUCHSOLTA MEDICALCBT-HP-14402020-07-13
00816995027324CLEAR+BRILLIANT TOUCHSOLTA MEDICALCBT-HP-19272020-07-13
00816995027331CLEAR+BRILLIANT TOUCHSOLTA MEDICALCBT-KEY-122020-07-13
B58613752Skin Renu LaserTria Laser IncSRL2020-07-13
08174950202202Cbeam 10MM Handpiece AssemblyCandela Corporation7122-00-30802016-09-23
08174950202219Cbeam 5MM Handpiece AssemblyCandela Corporation7122-00-31502016-09-23
08174950202226Cbeam 7MM Handpiece AssemblyCandela Corporation7122-00-31512016-09-23
00817495021386PicoWay Zoom Handpiece AssemblyCandela Corporation7122-00-40522016-09-23
00817495021546PicoWay Resolve Hand-Pieces and Distance Gauge KitCandela Corporation7123-00-00722016-09-23
00817495021782Vbeam Delivery System Assembly, JapanCandela Corporation0800-00-10952016-09-23
00817495021911Diode Handpiece AssemblyCandela Corporation7122-00-20502016-10-03
00817495022147Vbeam Handpiece AssemblyCandela Corporation7122-00-06702016-09-23
00817495022239Vbeam 7MM Delivery System W/O DCDCandela Corporation7122-00-31562016-09-23
00817495022246Vbeam 5MM Delivery System W/O DCDCandela Corporation7122-00-31572016-09-23
00817495022253Vbeam 6MM Diode Handpiece AssemblyCandela Corporation7122-00-32112016-09-23
00817495022260Vbeam 8MM Delivery System W/DCDCandela Corporation7122-00-33072016-09-23
00817495022277Vbeam 15MM Delivery System W/DCDCandela Corporation7122-00-33112016-09-23
00817495022284Vbeam 18MM Delivery System W/DCDCandela Corporation7122-00-33132016-09-23
00817495022406PicoWay Resolve 532 Handpiece AssemblyCandela Corporation7123-00-00582016-09-23
00817495022413PicoWay Resolve 1064 Handpiece AssemblyCandela Corporation7123-00-00592016-09-23
00817495022536FSE VB2 Perfecta Delivery SystemCandela Corporation7122-57-36922016-10-03
00817495022574PICOWAY Resolve HiEnergy Handpiece and Distance Gauge KitCandela Corporation7123-00-02142016-10-03
00817495022666532 Resolve Handpiece, High Energy AssemblyCandela Corporation7123-00-02092016-10-14
00817495022673785 Handpiece AssemblyCandela Corporation7123-00-01912016-10-26
00817495022680Kit, 785 HP and DGCandela Corporation7123-00-02452016-10-26
00817495022734Refurbed PICO 532 Resolve HP, HiECandela Corporation7123-57-02092018-01-12
00817495022741Refurbed PICO 1064 Resolve HPCandela Corporation7123-57-00592018-01-12
00817495022758Refurbed PICO 532 Resolve HPCandela Corporation7123-57-00582018-01-12
00817495021348Vbeam Perfecta Delivery SystemCandela Corporation0800-00-03102016-09-23
00817495021355COT Injector Bottle AssemblyCandela Corporation7121-00-22702016-09-23
00817495021362Vbeam Perfecta Delivery SystemCandela Corporation7122-00-36922016-09-23
00817495021409Vbeam Platinum Delivery SystemCandela Corporation0800-00-03202016-09-23
00817495021416Vbeam Platinum Distance Gauge Kit Candela Corporation7122-00-37552016-09-23
00817495021423Vbeam Platinum Delivery SystemCandela Corporation7122-00-36912016-09-23
00817495021430Vbeam Aesthetica Delivery SystemCandela Corporation0800-00-03302016-09-23
00817495021447Vbeam Aesthetica Delivery SystemCandela Corporation7122-00-36902016-09-23
00817495021454Vbeam Aesthetica Distance Gauge KitCandela Corporation7122-00-37542016-09-23
00817495021591Vbeam Delivery System AssemblyCandela Corporation0800-00-10712016-09-23
00817495022512VPYAG-LE 8MM RGD Fiber AssemblyCandela Corporation7122-00-75402016-10-03
00817495022567FSE VPYAG 12/15/18 RGD Delivery SystemCandela Corporation7122-57-37922016-10-03
00817495022710Specialty Delivery System Kit , no 5mm SACandela Corporation7123-00-03072017-02-23
00817495022079GentleLase Pro 12/15/18MM Delivery System W/DCDCandela Corporation0800-00-10732016-09-23
00817495022086GentleLase LE 12MM Delivery System Candela Corporation0800-00-10742016-09-23
00817495022093GentleLase 18MM Delivery SystemCandela Corporation0800-00-10752016-09-23
00817495022109GentleMax Delivery SystemCandela Corporation0800-00-10802016-09-23
00817495022116GentleMax LE Delivery System W/O DCDCandela Corporation0800-00-10812016-09-23
00817495022123Alex 755 Delivery System DemoCandela Corporation0800-00-10932016-09-23
00817495022130Alex 755 Delivery System DemoCandela Corporation0800-00-10942016-09-23
00817495022154Alex TriVantage Delivery SystemCandela Corporation7122-00-09212016-09-23
00817495022161Alex TriVantage 3MM Handpiece AssemblyCandela Corporation7122-00-10512016-09-23
00817495022178Alex TriVantage 4MM Handpiece AssemblyCandela Corporation7122-00-10522016-09-23
00817495022185Alex TriVantage 2MM Handpiece AssemblyCandela Corporation7122-00-10532016-09-23
00817495022192Alex TriVantage 532/1064 Handpiece AssemblyCandela Corporation7122-00-12072016-09-23
00817495021133FootswitchCandela Corporation5103-00-00302016-09-23
00817495021140PRO Series Delivery System W/O FiberCandela Corporation7122-00-94012016-09-23
00817495021157PRO Series Fiber AssemblyCandela Corporation7122-00-94192016-09-23
00817495021164Specialty Delivery System AssemblyCandela Corporation7122-00-96152016-09-23
00817495021171Specialty Delivery System AssemblyCandela Corporation7122-00-96162016-09-23
00817495021188PRO Series Handpiece W/Air Clip W/O FIBERCandela Corporation7122-00-95852016-09-23