FDA.reportPublic FDA data

Edge ONE

Primary DI
08800020110015
Brand
Edge ONE
Company
Jeisys Medical Inc.
Model
Edge ONE
Device description
CO2 Fractional laser system
Published
2016-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162169000EdgeOne CO2 LaserJeisys Medical, Inc.2016-10-27GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
8800020110039PackageGS11In Commercial Distribution
08800020110015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
8800020110039088000201100398800020110039
08800020110015088000201100158800020110015

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
690275362
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800020108333DENSITY TipClassic-B Tip2026-03-16
08800020108340DENSITY TipClassic-E Tip2026-03-16
08800020108357DENSITY TipClassic-F Tip2026-03-16
08800020108364DENSITY TipHigh-B Tip2026-03-16
08800020108371DENSITY TipHigh-E Tip2026-03-16
08800020108388DENSITY TipHigh-F Tip2026-03-16
08800020101525POTENZANeutral Electrode Pad Cable2026-03-16
08800020108166DENSITYFoot switch2026-03-16
08800020108173DENSITYPower cord2026-03-16
08800020108180DENSITYNeutral Electrode Pad cable2026-03-16
08800020108197DENSITYHandpiece holder2026-03-16
08800020108203DENSITYHandpiece cradle2026-03-16
08800020108289DENSITY TipClassic-B Tip2026-03-16
08800020108272DENSITY TipClassic-E Tip2026-03-16
08800020108296DENSITY TipClassic-F Tip2026-03-16
08800020108302DENSITY TipHigh-B Tip2026-03-16
08800020108319DENSITY TipHigh-E Tip2026-03-16
08800020108326DENSITY TipHigh-F Tip2026-03-16
08800020108395POTENZAFoot Switch2026-03-16
08800020108401POTENZAPower Cable2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
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
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07