FDA.reportPublic FDA data

Hydrafacial Syndeo

Primary DI
00810007532400
Brand
Hydrafacial Syndeo
Company
Hydrafacial LLC
Model
240V Black
Catalog number
7000079-BLK
Device description
220-240VAC, 50/60Hz, 2A
Published
2024-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00810007532400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007532400008100075324008100075324000810007532400

GMDN Terms#

Term, Definition table
TermDefinition
Skin abrasion unitA mains electricity (AC-powered) device used for the removal of the skin surface by abrasion (applied by some kind of rotating abrasive tool, e.g., a wire brush or emery disc). It may be used during plastic surgery and can be used for treatments such as the removal of scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities of the skin. This GMDN code may reflect old technology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8006034996regulatory@hydrafacial.com

Regulatory Flags#

DUNS number
364134791
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
00810007533643Hydrafacial™ Syndeo™ BLACK 240V KOREA240V Black, Non Medical2026-03-27
00810007534251SKINSTYLUS STERILOCK MICROSYSTEMSKINSTYLUS STERILOCK MICROSYSTEM2026-03-27
00810007534268Hydrafacial™ SkinStylus™ Nano QuickStart Kit (Non Medical)Hydrafacial™ SkinStylus™ Nano QuickStart Kit (Non 2026-03-27
00810007534794Hydrafacial™ Elite System, 240V INTERNATIONAL240V Black, Non Medical70290-03-01-ITL2026-03-13
00810007532394Hydrafacial Syndeo 120V, Black7000078-BLK2024-07-11
00810007531311Hydrafacial MD Elite240V70290-03-012024-07-18
00810007531540Hydrafacial MD Elite120V70143-03-012024-07-18
00810007531595Hydrafacial MD Allegro120V704152024-07-18
00810007532479Hydrafacial Syndeo 120V, White7000078-WHT2024-07-18
00810007532486Hydrafacial Syndeo 240V White7000079-WHT2024-07-18
00810007532493Hydrafacial Syndeo 240V White No-Perk7000079-WHT-NPK2024-07-18
00810007532509Hydrafacial Syndeo 120V, White No Perk7000078-WHT-NPK2024-07-18
00810007532516Hydrafacial Syndeo240V Black No Perk7000079-BLK-NPK2024-07-18
00810007532523Hydrafacial Syndeo 120V, Black No Perk7000078-BLK-NPK2024-07-18
00810007533605Hydrafacial Syndeo 240V Black, Non Medical 7000079-BLK-NMD2024-07-18
00810007533711Hydrafacial Syndeo 120V Black, Non Medical7000078-BLK-NMD2024-07-18
00810007533728Hydrafacial Allegro SPA240V704142024-07-18
00810007533735Dior Syndeo240V Assembly7000079-BLK-DIOR2024-07-18
00810007533742Dior Syndeo120V Assembly7000078-BLK-DIOR2024-07-18
00810007533896Dior Syndeo 240V, White7000079-WHT-DIOR2024-07-18

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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
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
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