FDA.reportPublic FDA data

Dermatological 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, or a fibre doped with a glass/crystal element (known as fibre laser), to emit a high-power laser beam intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, acne treatment, and/or lesion/hair/tattoo removal; some types may also be used for coagulation/haemostasis procedures. It typically includes a light source, laser beam delivery/positioning device(s), user interface, and controls/foot-switch; it does not include frequency-doubling technology.
GUDID devices
403
Last updated
2025-06-23 15:22:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850039149078AuraLuxAcclaro CorporationMP-01-002722025-06-13
00850039149085AuraLuxAcclaro CorporationAS-SM-200002025-06-13
10850039149075AuraLuxAcclaro CorporationAS-KT-000142025-06-13
00817495023557Glase Pro U Laser SystemCandela Corporation9914-CH-90302022-12-16
00817495023564GMAX Pro Laser SystemCandela Corporation9914-CH-90352022-12-16
00817495023571GMAX Pro Plus Laser SystemCandela Corporation9914-CH-90362022-12-16
00817495023656GYAG Pro U Laser SystemCandela Corporation9914-CH-90202022-12-16
00816995027799Fraxel FTXSOLTA MEDICALMCSYSFTX-R2025-04-02
00850039149054AuraLuxAcclaro CorporationAS-AL-200002025-04-01
00850039149061DiamondLuxAcclaro CorporationAS-DL-200002025-04-01
08800022304412PICOALEXWONTECH CO.,LTDPICOALEX2025-03-25
08809447658063CLARITY IILutronic CorporationAIR TIP PACKAGE_USA2025-03-05
08809447657394MOSAIC 3DLutronic CorporationSapphire Tip (S20 Tip) Package2025-01-06
08809447657448MOSAIC 3DLutronic CorporationSapphire Tip (S10 Tip) Package2025-01-06
08809447657721CLARITY IILutronic CorporationTIP PACKAGE2024-12-27
08800016904925Reepot Set PackageCLASSYS Inc.VSLS2024-10-30
08800016904932Reepot Main UnitCLASSYS Inc.VSLS2024-10-30
08800016904949Reepot HandpieceCLASSYS Inc.VSLS2024-10-30
00817495024646Glase Pro U Laser SystemCandela Corporation9914-CH-90302024-09-24
00817495024653GMAX Pro Laser SystemCandela Corporation9914-CH-90352024-09-24
00817495024660GMAX Pro Plus Laser SystemCandela Corporation9914-CH-90362024-09-24
03830054230385AvalancheLaseFOTONA d.o.o.M071-2F/XP2024-09-20
08052049500234Splendor XBIOS SRLSplendor X Alex+Nd:YAG2024-07-02
08052049500241Splendor XBIOS SRLSplendor X Alex2024-07-02
08052049500258Splendor XBIOS SRLSplendor X Alex22024-07-02
08052049500265Splendor XBIOS SRLSplendor X Nd:YAG2024-07-02
00817495023946Modified LSDS Fiber Assembly, 12-26 mmCandela CorporationSBA1007752024-06-17
00817495023984GentleCool Pro Canister Cryogen (R134a / 980g / US)Candela CorporationFIN1033202024-05-23
00817495024004GentleCool Pro Packaged 15-Pack of Cryogen (R134a / 980g / US)Candela CorporationFIN1033212024-05-23
00817495020587Packaged 15-Pack of Cryogen (R134a / 980g / US)Candela Corporation1600-00-02192024-04-26
00817495023649Packaged 15-Pack of Cryogen (R134a / 980g / JP)Candela Corporation1600-00-02182024-04-26
07290117772447FoLiCool™ TipLUMENIS BE LTDNA2024-03-17
07290117772522FoLix™LUMENIS BE LTDNA2024-03-17
07290117772539FoLix™ HandpieceLUMENIS BE LTDNA2024-03-17
00817495024882Canister HFO-R1234 ZE / 950g, ALUM (US)Candela CorporationFIN1010982024-02-02
00817495024905Canister HFO-R1234 ZE / 950g, ALUM (Japan)Candela CorporationFIN1011002024-02-02
00817495024943Canister HFO-R1234 ZE / 950g, ALUM, 3 Pack (US)Candela CorporationFIN1011042024-02-02
00817495024967Canister HFO-R1234 ZE / 950g, ALUM, 3 Pack (Japan)Candela CorporationFIN1011062024-02-02
00817495025001Canister HFO-R1234 ZE / 950g, ALUM, 15 Pack (US) Candela CorporationFIN1011102024-02-02
00817495025025Canister HFO-R1234 ZE / 950g, ALUM, 15 Pack (Japan) Candela CorporationFIN1011122024-02-02
07290117772393LUSTER SystemLUMENIS BE LTDNA2024-01-22
07290117772409LUSTER HandpieceLUMENIS BE LTDNA2024-01-22
07290117772416LUSTER Tip, RoundLUMENIS BE LTDNA2024-01-22
00850039149009UltraClearAcclaro CorporationAS-BB-000552023-08-25
00850039149429UltraClearAcclaro CorporationAS-WB-000552023-08-25
00850017374188LaserMeNEAUVIA NORTH AMERICA, INC.100-16002023-08-15
08034108512426ERISE Laser HandpieceDEKA M.E.L.A. SRLE262B12023-06-16
07290110240042OMNIMAX S4SharpLight Technologies Ltd.OMNIMAX-S42023-05-21
07290110240073Rapid PeelSharpLight Technologies Ltd.RAPID–PEEL2023-05-22
07290110240127Rapid VanishSharpLight Technologies Ltd.RAPID-VANISH2023-05-22
07290110240134Rapid QSSharpLight Technologies Ltd.RAPID-QS2023-05-22
00817495024592Pro Delivery System, RefurbishedCandela CorporationFIN1009852023-05-01
08800088900009Long Pulsed LaserELEMENIC CO.,LTD.ELEMENT-TL2023-03-30
03830054230361AvalancheLaseFOTONA d.o.o.M071-2F/LXP2023-03-07
03830054230378AvalancheLaseFOTONA d.o.o.M071-2F/LX2023-03-07
08800022304108SANDRO DualWONTECH CO.,LTDSANDRO Dual2020-06-16
00817495024127GentleMAX PRO PLUS Laser SystemCandela Corporation9914-00-90362022-12-05
08059173392230Accure QUANTA SYSTEM SPAPFMS000042022-12-01
00817495024080Refurbished GentleMax Pro PlusCandela Corporation9914-58-90362022-11-29
00817495024097Refurbished GentleMax ProCandela Corporation9914-57-90352022-11-29
00817495024103Refurbished GentleMax ProCandela Corporation9914-58-90352022-11-29
00817495024110Refurbished GentleMax Pro PlusCandela Corporation9914-57-90362022-11-29
00817495020044 GentleYAG Pro-U Candela Corporation 9914-00-9020 2016-09-23
00817495020068GentleLASECandela Corporation9914-00-90402016-09-23
00817495020273GentleMax ProCandela Corporation9914-00-9335 2016-09-23
00817495021805GentleLaseCandela Corporation9914-00-08832016-09-23
00817495021812GentleLase Pro Candela Corporation9914-11-90152016-09-23
00817495021829GentleLase Pro Candela Corporation9914-00-08872016-09-23
00817495021874GentleYAGCandela Corporation9914-00-09522016-09-23
00817495021881GentleYAGCandela Corporation9914-00-09572016-09-23
00817495021898GentleYAGCandela Corporation9914-00-09602016-09-23
00817495022024GentleLase Pro Candela Corporation9914-00-93302016-09-23
00850017374201EpilMe SystemNEAUVIA NORTH AMERICA, INC.300-16012022-10-03
00850017374218EpilMe ApplicatorNEAUVIA NORTH AMERICA, INC.300-17012022-10-03
00817495023632Canister HFC-134a / 980g, ALUM Candela Corporation1600-00-02232022-09-27
00817495023618Canister HFC-134a /980g, ALUM, 3 pack Candela Corporation1600-00-02302022-09-23
00817495023625Canister HFC-134a /980g, ALUM, 12 pack Candela Corporation1600-00-02312022-09-23
00817495023670Canister HFC-134a /980g, ALUM, 15 pack Candela Corporation1600-00-02242022-09-23
00817495023601Canister HFC-134a /980g, ALUM, 1 pack Candela Corporation1600-00-02292022-09-22
00817495022970GentleMax Pro PlusCandela Corporation9914-15-90362022-05-20