FDA.reportPublic FDA data

MOSAIC 3D

Primary DI
08800291821092
Brand
MOSAIC 3D
Company
Cynosure Lutronic Technology Corporation
Model
Roller Tip Package
Device description
8800291820996 Roller Tip 4ea,Roller Set 4set
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
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800291821092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800291821092088002918210928800291821092

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological solid-state laser systemA 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 is not intended for hair loss therapy. 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.

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
08800291821801eCO2 DENTAeCO2 DENTA_220V2026-06-25
08800291820200DermaVDermaV2026-06-23
08800291820323HEALITE IIHEALITE II(830nm)_110V2026-06-23
08800291820040CLARITY IICLARITY II2026-06-22
08800291820057CLARITY IICLARITY II2026-06-22
08800291820187CLARITY IITIP PACKAGE_USA2026-06-22
08800291820460HOLLYWOOD SPECTRAHOLLYWOOD SPECTRA2026-06-22
08800291820477HOLLYWOOD SPECTRAHOLLYWOOD SPECTRA2026-06-22
08800291820484HOLLYWOOD SPECTRAHOLLYWOOD SPECTRA2026-06-22
08800291820859PICOPLUSPICOPLUS2026-06-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16