FDA.reportPublic FDA data

General/multiple surgical 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, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). 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
271
Last updated
2026-06-11 06:06:16

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06970285176018Powered Laser Surgical Instrument APOLLO V+ Medical PlatformBeijing Syntech Laser Co., Ltd.MLP-012017-06-30
06970285176025Powered Laser Surgical Instrument APOLLO IV+ Medical PlatformBeijing Syntech Laser Co., Ltd.MLP-022017-06-30
06970285176049Powered Laser Surgical Instrument Nice Station Light Based PlatformBeijing Syntech Laser Co., Ltd.MLP-042017-06-30
00841494100476SlimlipoTip 175 mm, EOCynosure, LLC0320-00312016-09-24
04049471091496VISULASCarl Zeiss Meditec AGVISULAS combi2026-01-12
04049471091502VISULAS greenCarl Zeiss Meditec AGVISULAS green2026-01-12
04712826770895LightLas 532LIGHTMED CORPORATIONLC0014(5W)2019-08-06
04712826770918SYL-9000 YAG LaserLIGHTMED CORPORATIONYL00242019-11-26
04712826771052SYL-9000 YAG LaserLIGHTMED CORPORATIONYL00262020-11-17
04712826771069SYL-9000 YAG LaserLIGHTMED CORPORATIONYL00272020-11-17
04712826771076Lightlas SeLecTor DeuxLIGHTMED CORPORATIONST00252020-11-17
04712826771083Lightlas SeLecTor DeuxLIGHTMED CORPORATIONST00262020-11-17
06971782584252Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.Boston Pico7552026-05-10
06971782584269Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.Boston PICO2026-05-10
08714729984375GreenLight™ Laser System FootswitchBOSTON SCIENTIFIC CORPORATION5110-00142019-02-20
08800035500009HELIOS Ⅲ bodyLaseroptek Co.,LtdHELIOS Ⅲ body2018-01-10
08800035500016HELIOS Ⅲ ArmLaseroptek Co.,LtdHELIOS Ⅲ Arm2018-01-10
08800035500023HELIOS Ⅲ Zoom HandpieceLaseroptek Co.,LtdHELIOS Ⅲ Zoom Handpiece2018-01-10
08800035500030HELIOS Ⅲ 532 Fractional HandpieceLaseroptek Co.,LtdHELIOS Ⅲ 532 Fractional Handpiece2018-01-10
08800035500047HELIOS Ⅲ 1064 Fractional HandpieceLaseroptek Co.,LtdHELIOS Ⅲ 1064 Fractional Handpiece2018-01-10
08800035500054HELIOS Ⅲ Collimator HandpieceLaseroptek Co.,LtdHELIOS Ⅲ Collimator Handpiece2018-01-10
08800035500061HELIOS Ⅲ User ManualLaseroptek Co.,LtdHELIOS Ⅲ User Manual2018-01-10
08800035500078HELIOS Ⅲ Service ManualLaseroptek Co.,LtdHELIOS Ⅲ Service Manual2018-01-10
08800035500085HELIOS Ⅱ power cableLaseroptek Co.,LtdHELIOS Ⅱ power cable2018-01-10
08800035500108HELIOS Ⅲ Foot SwitchLaseroptek Co.,LtdHELIOS Ⅲ Foot Switch2018-01-10
08800035500115HELIOS Ⅲ Power CableLaseroptek Co.,LtdHELIOS Ⅲ Power Cable2018-01-10
08800035500122HELIOS Ⅱ bodyLaseroptek Co.,LtdHELIOS Ⅱ body2018-01-10
08800035500139HELIOS Ⅱ ArmLaseroptek Co.,LtdHELIOS Ⅱ Arm2018-01-10
08800035500146HELIOS Ⅱ Zoom HandpieceLaseroptek Co.,LtdHELIOS Ⅱ Zoom Handpiece2018-01-10
08800035500153HELIOS Ⅱ 532 Fractional HandpieceLaseroptek Co.,LtdHELIOS Ⅱ 532 Fractional Handpiece2018-01-10
08800035500160HELIOS Ⅱ 1064 Fractional HandpieceLaseroptek Co.,LtdHELIOS Ⅱ 1064 Fractional Handpiece2018-01-10
08800035500177HELIOS Ⅱ Collimator HandpieceLaseroptek Co.,LtdHELIOS Ⅱ Collimator Handpiece2018-01-10
08800035500184HELIOS Ⅱ User ManualLaseroptek Co.,LtdHELIOS Ⅱ User Manual2018-01-10
08800035500191HELIOS Ⅱ Service ManualLaseroptek Co.,LtdHELIOS Ⅱ Service Manual2018-01-10
08800035500207HELIOS Ⅱ Foot SwitchLaseroptek Co.,LtdHELIOS Ⅱ Foot Switch2018-01-10
08800035500788HELIOS III bodyLaseroptek Co.,LtdHELIOS III body2019-11-21
08800035501426HELIOS IV 785 BodyLaseroptek Co.,LtdHELIOS IV 785 Body2022-06-21
08800035501563HELIOS IV 785 BodyLaseroptek Co.,LtdHELIOS IV 785 Body2022-06-21
08800035501617HELIOS 785 Pico BodyLaseroptek Co.,LtdHELIOS 785 Pico Body2023-01-05
08800035501761PALLAS Premium BodyLaseroptek Co.,LtdPALLAS Premium Body2023-02-08
08800035501860HELIOS 785 Pico BodyLaseroptek Co.,LtdHELIOS 785 Pico (1754V2) Body2025-02-18
08809447650272SPECTRALutronic CorporationSPECTRA SL body U120V2016-07-27
08809447650333N/ALutronic CorporationSpectra-standard ARM2016-11-02
08809447650777N/ALutronic CorporationSpectra Lotion2016-07-27
08809447652016PICOPLUSLutronic CorporationPICOPLUS 220V2018-08-03
08809447652108N/ALutronic CorporationPICOPLUS ARM2018-08-03
08809447652146N/ALutronic CorporationOperator's Goggle (532/1064nm)2018-08-06
08809447652153N/ALutronic CorporationLUT FILTER Goggle (for Operator)2018-08-06
08809447652412N/ALutronic CorporationSpectra Lotion for KSA2019-02-13
08809447654676HOLLYWOOD SPECTRALutronic CorporationHOLLYWOOD SPECTRA OP2021-01-26
08809447654683HOLLYWOOD SPECTRALutronic CorporationHOLLYWOOD SPECTRA SL2021-01-26
08809447654706HOLLYWOOD SPECTRALutronic CorporationARM_VA20_D-GRAY2021-01-26
10841494100374PrecistionTx Handpiece, 2 PackCynosure, LLC100-7019-0152018-08-22
10841494100398Smartlipo Fiber w/ RFID, 600um Fiber, 10 packCynosure, LLC807-5001-6142018-08-22
10841494100404SideLaze 3D Fiber w/RFID, 1000um, 10 packCynosure, LLC807-5001-6162018-08-22
10841494100411SideLaze800 Fiber w/RFID, 800um, 10 packCynosure, LLC807-5001-6182018-08-22
10841494100428Smartlipo Fiber w/ RFID, 1000um Fiber, 10 packCynosure, LLC807-5001-6202018-08-22
10841494103474Cellulaze Handpiece, 2 PackCynosure, LLC100-7014-0152018-08-24
00199284314580CPMT Ares – Quadruple Laser SystemCanadian Pioneer Medical Technology CorporationCPMT Ares 2025-07-08
00199284747210TORLASE-Alexandrite and Nd: Yag laser Canadian Pioneer Medical Technology CorporationTORLASE 2025-07-08
08800042100292PICO LEGENDAMI Inc.PICO LEGEND2025-06-10
08800035500740HELIOS III bodyLaseroptek Co.,LtdHELIOS III body2019-11-21
08800035500795HELIOS III ArmLaseroptek Co.,LtdHELIOS III Arm2019-11-21
08800035500801HELIOS III Zoom HandpieceLaseroptek Co.,LtdHELIOS III Zoom Handpiece2019-11-21
08800035500818HELIOS III 532 HandpieceLaseroptek Co.,LtdHELIOS III 532 Handpiece2019-11-21
08800035500825HELIOS III 1064 HandpieceLaseroptek Co.,LtdHELIOS III 1064 Handpiece2019-11-21
08800035500832HELIOS III Collimator HandpieceLaseroptek Co.,LtdHELIOS III Collimator Handpiece2019-11-21
08800035500849HELIOS III User ManualLaseroptek Co.,LtdHELIOS III User Manual2019-11-21
08800035500856HELIOS III Service ManualLaseroptek Co.,LtdHELIOS III Service Manual2019-11-21
08800035500863HELIOS III Foot SwitchLaseroptek Co.,LtdHELIOS III Foot Switch2019-11-21
08800035500870HELIOS III Power CableLaseroptek Co.,LtdHELIOS III Power Cable2019-11-21
08800022302906Pastelle ProWONTECH CO.,LTDPastelle Pro2025-02-24
08800035501877HELIOS 785 Pico ArmLaseroptek Co.,LtdHELIOS 785 Pico (1754V2) Arm2025-02-18
08800035501884HELIOS 785 Pico Zoom HandpieceLaseroptek Co.,LtdHELIOS 785 Pico (1754V2) Zoom Handpiece2025-02-18
08800035501891HELIOS 785 Pico Zoom Collimator HandpieceLaseroptek Co.,LtdHELIOS 785 Pico (1754V2) Zoom Collimator Handpiece2025-02-18
08800035501907HELIOS 785 Pico 1064 FX HandpieceLaseroptek Co.,LtdHELIOS 785 Pico (1754V2) 1064 FX Handpiece2025-02-18
08800035501914HELIOS 785 Pico 785 Zoom HandpieceLaseroptek Co.,LtdHELIOS 785 Pico (1754V2) 785 Zoom Handpiece2025-02-18
08800035501921HELIOS 785 Pico 785 Collimator HandpieceLaseroptek Co.,LtdHELIOS 785 Pico (1754V2) 785 Collimator Handpiece2025-02-18
08800035501938HELIOS 785 Pico DIA FX 785 s HandpieceLaseroptek Co.,LtdHELIOS 785 Pico (1754V2) DIA FX 785 s Handpiece2025-02-18
08800035501945HELIOS 785 Pico 532 FX HandpieceLaseroptek Co.,LtdHELIOS 785 Pico (1754V2) 532 FX Handpiece2025-02-18