FDA.reportPublic FDA data

Ibramed

Primary DI
07898961579139
Brand
Ibramed
Company
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Model
Dermotonus Esthetic
Catalog number
01006005
Device description
DERMOTONUS ESTHETIC is a device which allows treatments in the Health, Medical and Cosmetic areas, and which does not present systemic side-effects or causes dependency. DERMOTONUS ESTHETIC is a multifunctional equipment, used in the techniques of mechanical massage and vacuum therapy and in two modes of microdermabrasion: crystal peeling and diamond peeling.
Published
2017-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
07898961579139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898961579139078989615791397898961579139

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
903359565
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898961579023IbramedNEUROTONUS PORTABLE TENS010020242017-10-13
07898961579030IbramedNEUROTONUS PORTABLE TENS FES010020252017-10-13
07898961579047IbramedNEUROTONUS II010020202017-10-13
07898961579054IbramedNEUROTONUS Compact010020212017-10-13
07898961579061IbramedCELLEBRA Compact 1MHz010040192017-10-13
07898961579078IbramedCELLEBRA Compact 3MHz010040202017-10-13
07898961579085IbramedCELLEBRA III010040182017-10-13
07898961579092IbramedCELLEBRA010040212017-10-13
07898961579108IbramedNEUROTONUS MULTIWAVE010020232017-10-13
07898961579115IbramedAUSSIE SPORT010020222017-10-13
07898966442551IbramedNEURODYN AUSSIE V2.02026-04-22
07898966442698IbramedNEURODYN V2.02026-04-22
07898966442933IbramedCryotecar2025-02-25
07898966442940IbramedNeartek2025-02-25
07898966442957IbramedDermotonus Esthetic2025-02-25
07898966442964IbramedHooke2025-02-25
07898961579146IbramedHF IBRAMED10070112017-10-13
07898961579122IbramedDermotonus Slim 010060062017-10-13
07898961579016IbramedNEURODYN MULTIWAVE2017-03-17

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