FDA.reportPublic FDA data

Dermatological frequency-doubled solid-state laser system

Definition
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended to cut, excise, ablate, and vaporize soft tissues in dermatological applications such as vascular/skin lesion, tattoo, and hair removal; it includes frequency doubling technology whereby the operator can select one of two energy wavelengths (1064 or 532 nm). It includes a light source, delivery/positioning device(s), and controls/foot-switch, and may be operated in continuous-wave or pulsed modes.
GUDID devices
77
Last updated
2021-08-04 11:13:14

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08059173392315Nanostar C QUANTA SYSTEM SPAPCMS003502021-07-26
08059173392322Nanostar YQUANTA SYSTEM SPAPCMS003512021-07-26
08059173392339Nanostar RQUANTA SYSTEM SPAPCMS003522021-07-26
08800042100001Q-MASTERAMI Inc.Q-MASTER2021-06-15
08800035501181PicoLO ArmLaseroptek Co.,LtdPicoLO Arm2021-04-23
08800035501198PicoLO 532 HandpieceLaseroptek Co.,LtdPicoLO 532 Handpiece2021-04-23
08800035501204PicoLO Collimator HandpieceLaseroptek Co.,LtdPicoLO Collimator Handpiece2021-04-23
08800035501211PicoLO Zoom HandpieceLaseroptek Co.,LtdPicoLO Zoom Handpiece2021-04-23
08800035501228PicoLO 1064 HandpieceLaseroptek Co.,LtdPicoLO 1064 Handpiece2021-04-23
08800035501235PicoLO User ManualLaseroptek Co.,LtdPicoLO User Manual2021-04-23
08800035501242PicoLO Foot SwitchLaseroptek Co.,LtdPicoLO Foot Switch2021-04-23
08800035501259PicoLO BodyLaseroptek Co.,LtdPicoLO Body2021-04-23
06971513121039KESBeijing KES Biology Technology Co.,Ltd.MED-810A2021-03-25
03830054230484StarWalkerFOTONA d.o.o.M031-3A/2 PQX2021-01-28
08059173391806Chrome QUANTA SYSTEM SPA PNMS001892020-12-22
08059173391813Chrome QUANTA SYSTEM SPA PNMS001902020-12-22
08800035501150PicoLO User ManualLaseroptek Co.,LtdRev.32020-10-28
06970745912989ApolomedShanghai Apolo Medical Technology Co.,LtdHS-298K2020-07-21
00817495020037PicoWayCandela Corporation9914-00-90602016-09-23
00817495021010PicoWayCandela Corporation9914-12-90602016-09-23
00817495021393PicoWayCandela Corporation9914-40-90602016-09-23
00817495022819PicoWay Laser System CPOCandela Corporation9914-05-90602018-09-25
00817495022581AlexLAZRCandela Corporation9914-12-20112016-10-03
00817495022598AlexLAZRCandela Corporation9914-13-20112016-10-03
00817495022604AlexLAZRCandela Corporation9914-11-20112016-10-03
00817495022611AlexLAZRCandela Corporation9914-00-20172016-10-03
00817495020297Alex TriVantage Candela Corporation9914-00-2325 2016-09-23
00817495020846Alex TriVantage Candela Corporation9914-00-20262016-09-23
00817495020853Alex TriVantage Candela Corporation9914-00-20272016-09-23
00817495020860Alex TriVantage Candela Corporation9914-KK-20252016-09-23
00817495020204Alex TriVantage Candela Corporation9914-00-2011 2016-09-23
00841494100193Medlite C6Cynosure, LLC659-0020-12016-09-24
00841494100209Medlite C6Cynosure, LLC659-0030-12016-09-24
00841494100216Revlite System, 220V +Cynosure, LLC661-0020-12016-09-24
00841494100223RevLite II System 220VCynosure, LLC661-10002016-09-24
00841494100315585nm Dye Hanpiece, GoldCynosure, LLC100-7017-0602016-09-24
00841494100322650nm Dye Handpiece, RedCynosure, LLC100-7017-0612016-09-24
00841494100339585nm Revlite SI Dye Handpiece, GoldCynosure, LLC100-7017-0622016-09-24
00841494100346650nm Revlite SI Dye Handpiece, RedCynosure, LLC100-7017-0632016-09-24
00841494100544Metal Cone, one pieceCynosure, LLC659-11542016-09-24
00841494103637MultiLite Dye Handpiece KirCynosure, LLC100-7017-0672016-09-24
00841494103651SI Dye Handpiece KitCynosure, LLC100-7017-0682016-09-24
08800035500986PicoLO User ManualLaseroptek Co.,LtdPicoLO User Manual(Rev. 2)2020-03-06
00816722022363CoolViewCUTERA, INC.CoolView2020-02-04
00841494108038Laser System, Vectus, BrazilCynosure, LLC105-3500-1002020-01-31
00816722022349DermastatCUTERA, INC.Dermastat 2mm2019-07-15
06970745912903ApolomedShanghai Apolo Medical Technology Co.,LtdHS-290K2020-01-06
06970745912910ApolomedShanghai Apolo Medical Technology Co.,LtdHS-290EK2020-01-06
08800035500610PicoLO BodyLaseroptek Co.,LtdPicoLO Body2019-01-31
08033945934088DominoQUANTA SYSTEM SPAPAMS00033 2016-08-18
08033945934095Light AQUANTA SYSTEM SPAPAMS000342016-08-18
08033945934101Q-Plus CQUANTA SYSTEM SPAPCMS003152016-08-18
08033945934118LIGHT BQUANTA SYSTEM SPAPCMS003162016-08-18
08033945934125Light A Star QUANTA SYSTEM SPAPCMS003172016-08-18
08033945934132Light C QUANTA SYSTEM SPAPCMS003182016-08-18
08033945934156MDK 1QUANTA SYSTEM SPAPCMS003202016-08-18
08033945934163MDK 2QUANTA SYSTEM SPAPCMS003212016-08-18
08033945934170MDK 3QUANTA SYSTEM SPAPCMS003222016-08-18
08033945934187Q-plus A QUANTA SYSTEM SPAPCMS003232016-08-18
08033945934217Q-Plus R QUANTA SYSTEM SPAPCMS003262016-08-18
08059173390601Discovery Pico DermQUANTA SYSTEM SPAPCMS0003372019-02-15
00816722021311excel V+CUTERA, INC.excel V+2019-07-15
00816722022325CoolViewCUTERA, INC.CoolView2019-07-15
00816722022356Genesis VCUTERA, INC.Genesis V2019-07-15
08167222022349DermastatCUTERA, INC.Dermastat 2mm2019-07-15
08809578390016Q-Switched Nd:YAG LaserIDS LtdQ102019-06-03
04058784000064TattooStar Effect COMBOAsclepion Laser Technologies GmbH16802016-11-14
04058784000125TattooStar RAsclepion Laser Technologies GmbH16402018-08-23
05700002052209ADVATxAdvalight ApS1.02016-09-18
00816722021304excel VCUTERA, INC.excel V2016-09-23
00816722021601enlightenCUTERA, INC.enlighten Standard2016-09-23
00816722021618enlightenCUTERA, INC.enlighten Low Energy Green2016-09-23
00816722021625enlightenCUTERA, INC.enlighten SR2018-03-02
00816722021649enlightenCUTERA, INC.enlighten III2016-12-08
00816722022301CoolViewCUTERA, INC.CoolView2016-09-23
00816722022318Genesis VCUTERA, INC.Genesis V2016-09-23
00816722023605enlightenCUTERA, INC.Micro Lens Array2019-01-14