FDA.reportPublic FDA data

JET CLEAR

Primary DI
08800060501675
Brand
JET CLEAR
Company
EUNSUNG GLOBAL CORP.
Model
ESM-3000MO
Device description
The jet gun sprays water and pressurized air to perform fine exfoliation, removing dead skin cell, while the spray handpiece sprays fine particles of solution, helping the solution to penetrate deep into the skin.
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GFEBrush, Dermabrasion, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800060501672PackageGS11In Commercial Distribution
28800060501679PackageGS12In Commercial Distribution
38800060501676PackageGS14In Commercial Distribution
48800060501673PackageGS16In Commercial Distribution
08800060501675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880006050167218800060501672
2880006050167928800060501679
3880006050167638800060501676
4880006050167348800060501673
08800060501675088000605016758800060501675

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689372738
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800060501644HYDRA BEAUTYESK-2212HB2022-09-22
08800060501651HYDRA TOUCH H2ESK-2253HH2022-09-22
08800060501668HYPER JETESK-2162HJ2022-09-22
08800060501682V-ROLLIA-100VR2022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800102500376Hydro 3D TipHealux Co.,LtdGFE2026-07-07
08800102500383Hydro 3D TipHealux Co.,LtdGFE2026-07-07
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