FDA.reportPublic FDA data

HYPER JET

Primary DI
08800060501668
Brand
HYPER JET
Company
EUNSUNG GLOBAL CORP.
Model
ESK-2162HJ
Device description
While vibrating at a high speed, the microtips of this device apply physical stimulation to the facial skin to facilitate active ingredients to penetrate in 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
08800060501668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800060501668088000605016688800060501668

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
08800060501675JET CLEARESM-3000MO2022-09-22
08800060501682V-ROLLIA-100VR2022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053782384136T-FACEB&M SRL MARKETING NEL BENESSEREGFE2026-05-27
08809455602829LHALA JETMETA SYSTEMS CO., LTD.GFE2026-04-23
00860015460653Nextgen Facial MachineT AESTHETICS LLCGFE2026-03-31
00810007533643Hydrafacial™ Syndeo™ BLACK 240V KOREAHydrafacial LLCGFE2026-03-27
00810007534251SKINSTYLUS STERILOCK MICROSYSTEMHydrafacial LLCGFE2026-03-27
00810007534268Hydrafacial™ SkinStylus™ Nano QuickStart Kit (Non Medical)Hydrafacial LLCGFE2026-03-27
08053782383733T-FACEB&M SRL MARKETING NEL BENESSEREGFE2026-03-25
00810007534794Hydrafacial™ Elite System, 240V INTERNATIONALHydrafacial LLCGFE2026-03-13
00850017374225Zaffiro IR Treatment Body ApplicatorNEAUVIA NORTH AMERICA, INC.GFE2026-02-11
00860009525108MediSpaMEDICREATIONS LLCGFE2026-02-11
00817495024622Glace Candela CorporationGFE2025-10-07
00817495025292Glace Candela CorporationGFE2025-10-07
00817495025308Glace Candela CorporationGFE2025-10-07
00817495025315Glace Candela CorporationGFE2025-10-07
00817495025339Glace Candela CorporationGFE2025-10-07
00817495025346Glace Candela CorporationGFE2025-10-07
00817495025353Glace Candela CorporationGFE2025-10-07
00817495025360Glace Candela CorporationGFE2025-10-07
00817495025377Glace Candela CorporationGFE2025-10-07
00817495025384Glace Candela CorporationGFE2025-10-07
00817495025391Glace Candela CorporationGFE2025-10-07
00817495025407Glace Candela CorporationGFE2025-10-07
00817495025414Glace Candela CorporationGFE2025-10-07
00817495025421Glace Candela CorporationGFE2025-10-07
00817495025438Glace Candela CorporationGFE2025-10-07
G050DOXYLIGHTIONIX0OXYLIGHTRAJA MedicalGFE2025-09-24
05391540830826Préime DermaFacialEMA AESTHETICS LIMITEDGFE2025-09-15
00810007534756Hydrafacial™ Lip TipHydrafacial LLCGFE2025-07-16
00810007534763HydraScalp™ Tip, Purify, 6-PackHydrafacial LLCGFE2025-07-16
00810007534770HydraScalp™ Tip, Nourish, 6-PackHydrafacial LLCGFE2025-07-16