FDA.reportPublic FDA data

INTRAgen Tip

Primary DI
18800020101218
Brand
INTRAgen Tip
Company
Jeisys Medical Inc.
Model
KT-15
Device description
INTRAgen Tip (KT-15)
Published
2022-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OUHSkin Resurfacing Rf Applicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUHSkin Resurfacing Rf ApplicatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142833000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142833000INTRAGenJeisys Medical, Inc.2015-06-04OUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800020101218PackageGS110In Commercial Distribution
08800020101211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880002010121818800020101218
08800020101211088000201012118800020101211

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring system applicator tipA removable endpiece that is attached to a radio-frequency (RF) skin contouring system applicator (handpiece), used to regulate the delivery of RF energy to the patient during treatment. As a procedural safety measure, the device may permit the transfer of energy only when a correct surface contact is established. It may also be used to cool the skin and monitor its temperature to protect the epidermis during treatment. This is a single-use device.

Sterilization Methods#

Method table
Method

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
true
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
07290016814675EndyMed Intensif 10 pack tips package ENDYMED MEDICAL LTDOUH2026-05-07
07290016814569PRO MAX, System, 110VENDYMED MEDICAL LTDOUH2025-11-17
08800016903140Max-25CLASSYS Inc.OUH2025-07-02
08800016903171Max-M25CLASSYS Inc.OUH2025-07-02
08800016903423Max-25CCLASSYS Inc.OUH2025-07-02
08800016903447Max-64CCLASSYS Inc.OUH2025-07-02
08800016903454Max-M25CCLASSYS Inc.OUH2025-07-02
08800016905045QUADESSY Set PackageCLASSYS Inc.OUH2025-07-02
08800016905052QUADESSY Main UnitCLASSYS Inc.OUH2025-07-02
08800016905069QUADESSY Deeplus hand pieceCLASSYS Inc.OUH2025-07-02
07290016814668PURE DentAENDYMED MEDICAL LTDOUH2024-11-06
08800016903683Secret PRO Set PackageCLASSYS Inc.OUH2024-10-31
08800016903690Secret PRO Main UnitCLASSYS Inc.OUH2024-10-31
08800016903706Secret PRO Articulated ArmCLASSYS Inc.OUH2024-10-31
08800016903713Secret PRO Scanner HandpieceCLASSYS Inc.OUH2024-10-31
08800016903720Secret PRO Needle HanpdieceCLASSYS Inc.OUH2024-10-31
08800016903737Secret PRO Bigger HandpieceCLASSYS Inc.OUH2024-10-31
08800016903744Secret PRO Smartcure HandpieceCLASSYS Inc.OUH2024-10-31
08800016903195Fraxis Duo 25Pin Needle TipCLASSYS Inc.OUH2024-10-30
08800016903294Secret RF Main UnitCLASSYS Inc.OUH2024-10-30
08800016903300Secret RF Bigger HandpieceCLASSYS Inc.OUH2024-10-30
08800016903317Secret RF Smartcure Applicator With ElectrodesCLASSYS Inc.OUH2024-10-30
08800016903331Secret RF Small HandpieceCLASSYS Inc.OUH2024-10-30
08800016903621Fraxis DUO Set PackageCLASSYS Inc.OUH2024-10-30
08800016903638Fraxis Duo Main UnitCLASSYS Inc.OUH2024-10-30
08800016903645Fraxis Duo Articulated armCLASSYS Inc.OUH2024-10-30
08800016903652Fraxis Duo Scanner HandpieceCLASSYS Inc.OUH2024-10-30
08800016903669Fraxis Duo Needle HandpieceCLASSYS Inc.OUH2024-10-30
08800016903287Secret RF Set PackageCLASSYS Inc.OUH2024-10-25
07290016814408EndyMed PRO MAX, System, 110VENDYMED MEDICAL LTDOUH2024-05-16