FDA.reportPublic FDA data

Hydrafacial™ Syndeo™ BLACK 240V KOREA

Primary DI
00810007533643
Brand
Hydrafacial™ Syndeo™ BLACK 240V KOREA
Company
Hydrafacial LLC
Model
240V Black, Non Medical
Device description
220-240VAC, 50/60Hz, 2A
Published
2026-03-27
Public version status
New
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
00810007533643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007533643008100075336438100075336430810007533643

GMDN Terms#

Term, Definition table
TermDefinition
Dermabrasion 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 group of devices may reflect old technology.

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
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
00810007532400Hydrafacial Syndeo 240V Black7000079-BLK2024-07-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809455602829LHALA JETMETA SYSTEMS CO., LTD.GFE2026-04-23
00860015460653Nextgen Facial MachineT AESTHETICS LLCGFE2026-03-31
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
00198715351606CANLASE-Alexandrite and Nd: Yag laser Canadian Pioneer Medical Technology CorporationGFE2025-07-02
08800102500246HealFusion ProHealux Co.,LtdGFE2025-06-24