FDA.reportPublic FDA data

HYDRA BEAUTY

Primary DI
08800060501644
Brand
HYDRA BEAUTY
Company
EUNSUNG GLOBAL CORP.
Model
ESK-2212HB
Device description
Hydra Beauty is equipped with two functions. First, the ‘Aqua peel cleansing’ which is using chemical peel to help clear skin pores and eliminating hazardous wastes. Secondly, Low frequency radiofrequency (EP) stimulates muscle relaxation and hormone secretion for pain relief.
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
18800060501641PackageGS11In Commercial Distribution
28800060501648PackageGS12In Commercial Distribution
38800060501645PackageGS14In Commercial Distribution
08800060501644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880006050164118800060501641
2880006050164828800060501648
3880006050164538800060501645
08800060501644088000605016448800060501644

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
08800060501651HYDRA TOUCH H2ESK-2253HH2022-09-22
08800060501668HYPER JETESK-2162HJ2022-09-22
08800060501675JET CLEARESM-3000MO2022-09-22
08800060501682V-ROLLIA-100VR2022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850051554003XSONXXSONX LLCGFE2026-07-09
08800102500345Hydro 3D TipHealux Co.,LtdGFE2026-07-07
08800102500352Hydro 3D TipHealux Co.,LtdGFE2026-07-07
08800102500369Hydro 3D TipHealux Co.,LtdGFE2026-07-07
08800102500376Hydro 3D TipHealux Co.,LtdGFE2026-07-07
08800102500383Hydro 3D TipHealux Co.,LtdGFE2026-07-07
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
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