FDA.reportPublic FDA data

eCO2 3D

Primary DI
08800291821221
Brand
eCO2 3D
Company
Cynosure Lutronic Technology Corporation
Model
Scanner Tip Set(only static tip)
Device description
8800291821184 Static Tip 120 1ea8800291821191 Static Tip 300 1ea8800291821207 Static Tip 500 1ea
Published
2026-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ONGPowered Laser Surgical Instrument With MicrobeamFractional Output

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONGPowered Laser Surgical Instrument With MicrobeamFractional OutputGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800291821221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800291821221088002918212218800291821221

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological carbon dioxide laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam, intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, scar treatment, skin tightening, and lesion/hair/tattoo removal. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch.

Regulatory Flags#

DUNS number
963392930
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800291820675LUTRONIC GENIUSGENIUS G U110V2026-04-15
08800291820682LUTRONIC GENIUSGeniusSkin Handpiece2026-04-15
08800291820699LUTRONIC GENIUSGeniusM Handpiece2026-04-15
08800291820705LUTRONIC GENIUSGeniusX Handpiece2026-04-15
08800291820712LUTRONIC GENIUSGeniusL Handpiece2026-04-15
08800291820729LUTRONIC GENIUSM64Q2026-04-15
08800291820736LUTRONIC GENIUSM36Q2026-04-15
08800291820750LUTRONIC GENIUSM49D2026-04-15
08800291820774LUTRONIC GENIUSP14D2026-04-15
08800291820798LUTRONIC GENIUSP16D2026-04-15
08800291820811LUTRONIC GENIUSM81D2026-04-15
08800291820835LUTRONIC GENIUSG49D2026-04-15
08800291820965MOSAIC 3DS10 TIP2026-04-15
08800291820996MOSAIC 3DRoller tip2026-04-15
08800291821023MOSAIC 3DComb tip2026-04-15
08800291821054MOSAIC 3DPill tip2026-04-15
08800291821085MOSAIC 3DSapphire Tip Package2026-04-15
08800291821092MOSAIC 3DRoller Tip Package2026-04-15
08800291821160eCO2 3DScanner HP2026-04-15
08800291821177eCO2 3DRoller Tip2026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800291821160eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821177eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821184eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821191eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821207eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821214eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821238eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821245eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821252eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821269eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821276eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821283eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821290eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821306eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821313eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821320eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821337eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
06974077940023MLKJWeifang Mingliang Electronics Co., Ltd.ONG2025-09-17
06970745912323ApolomedShanghai Apolo Medical Technology Co.,LtdONG2025-07-21
06970745912330ApolomedShanghai Apolo Medical Technology Co.,LtdONG2025-07-21
08057622080004MTONE EVOM & T SRLONG2025-04-15
08057622080011MTONE EVOM & T SRLONG2025-04-15
08057622080028MT ONEM & T SRLONG2025-04-15
08057622080035MT ONEM & T SRLONG2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONG2025-04-15
G7433426Smooth Beauty LaserTria Laser IncONG2025-03-07
08800016903959Fraxis Set PackageCLASSYS Inc.ONG2024-10-30
08800016903966Fraxis Main UnitCLASSYS Inc.ONG2024-10-30
08800016903973Fraxis HandpieceCLASSYS Inc.ONG2024-10-30
08800016903980Fraxis Zoom HandpieceCLASSYS Inc.ONG2024-10-30