FDA.reportPublic FDA data

DermaV

Primary DI
08800291820200
Brand
DermaV
Company
Cynosure Lutronic Technology Corporation
Model
DermaV
Device description
DermaV(6.0K_USA)
Published
2026-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08800291820200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800291820200088002918202008800291820200

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800291821801eCO2 DENTAeCO2 DENTA_220V2026-06-25
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
08800291820811LUTRONIC GENIUSM81D2026-04-15

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