FDA.reportPublic FDA data

Hydro 3D Handpiece

Primary DI
08800102500406
Brand
Hydro 3D Handpiece
Company
Healux Co.,Ltd
Model
Handpiece
Published
2026-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
08800102500406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800102500406088001025004068800102500406

Contacts#

Phone, Email table
PhoneEmail
+82221692880andy.kim@gmail.com

Regulatory Flags#

DUNS number
695821746
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
08800102500345Hydro 3D TipHeal Tips2026-07-07
08800102500352Hydro 3D TipPro Tips2026-07-07
08800102500369Hydro 3D TipSkin Tips2026-07-07
08800102500376Hydro 3D TipBody Tips2026-07-07
08800102500383Hydro 3D TipScalp Tips2026-07-07
08800102500246HealFusion ProHealFusion Pro2025-06-24

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
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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