FDA.reportPublic FDA data

Footswitch

Primary DI
08800020109613
Brand
Footswitch
Company
Jeisys Medical Inc.
Model
971-SWNO210
Device description
971-SWNO210
Published
2026-07-16
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
ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
08800020109613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800020109613088000201096138800020109613

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
08800020100276INTRAcel TipINTRAcel Tip 10102026-07-16
08800020100283INTRAcel TipINTRAcel Tip 32026-07-16
08800020100306INTRAcel TipINTRAcel Tip 10122026-07-16
08800020100313INTRAcel TipINTRAcel Tip 10132026-07-16
08800020100320INTRAcel TipINTRAcel Tip 20112026-07-16
08800020100337INTRAcel TipN16 Tip2026-07-16
08800020104984DENSITY TipClassic-B Tip2026-07-16
08800020104991DENSITY TipClassic-E Tip2026-07-16
08800020105004DENSITY TipClassic-F Tip2026-07-16
08800020105059DENSITY TipHigh-B Tip2026-07-16
08800020105066DENSITY TipHigh-E Tip2026-07-16
08800020105073DENSITY TipHigh-F Tip2026-07-16
08800020106322TRI-BEAMTRI-BEAM PRO2026-07-16
08800020106827DENSITY TipALPHA TIP2026-07-16
08800020107626DENSITY HandpieceDT-HP-012026-07-16
08800020107633DENSITY HandpieceDT-HP-022026-07-16
08800020109446TRI-BEAM HandpieceZOOM Handpiece 012026-07-16
08800020109453TRI-BEAM HandpieceCollimation Handpiece 012026-07-16
08800020109460TRI-BEAM Handpiece1064 Fractional Handpiece 012026-07-16
08800020109477TRI-BEAM Handpiece532 Fractional Handpiece 012026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800020109576FootswitchJeisys Medical Inc.ONG2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.ONG2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.ONG2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.ONG2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.ONG2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.ONG2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.ONG2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.ONG2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.ONG2026-07-16
08800291821801eCO2 DENTACynosure Lutronic Technology CorporationONG2026-06-25
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
08800291821221eCO2 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