FDA.reportPublic FDA data

Ibramed

Primary DI
07898961579146
Brand
Ibramed
Company
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Model
HF IBRAMED
Catalog number
1007011
Device description
HF Ibramed is a portable high frequency piece of equipment for facial, body, capillary and podology application. Application frequency is monopolar, that is, only one electrode is used. The function of the gas inside the electrode is to induce the current flow. This gas is excited through the passage of electric current and produces a light, whose color depends on the type of gas used. The gas is then ionized by the high tension, making the glass bulb fluorescent.
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
KCXEpilator, High Frequency, Tweezer-Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCXEpilator, High Frequency, Tweezer-TypeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898961579146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898961579146078989615791467898961579146

GMDN Terms#

Term, Definition table
TermDefinition
Professional hair-removal electrolysis systemAn assembly of devices intended to permanently remove unwanted body hair by destroying the dermal papilla (hair root) through application of an electric current at the tip of a fine needle electrode that is inserted close to the hair shaft, under the skin, and into the dermal papilla. It typically includes an electrically-powered control unit, a handpiece that connects to the control unit and holds the disposable electrode, and a foot-switch. The system is typically available in three types: galvanic (applies DC), thermolysis/high-frequency (applies AC), and blend (applies DC/AC combination). It is intended to be operated by a trained professional and may be referred to as an epilator.

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
07898961579139IbramedDermotonus Esthetic010060052017-10-13
07898966442933IbramedCryotecar2025-02-25
07898966442940IbramedNeartek2025-02-25
07898966442957IbramedDermotonus Esthetic2025-02-25
07898966442964IbramedHooke2025-02-25
07898961579122IbramedDermotonus Slim 010060062017-10-13
07898961579016IbramedNEURODYN MULTIWAVE2017-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841013124693MicroquoreAMERICAN EAGLE INSTRUMENTS, INC.KCX2026-06-26
00841013124709MicroquoreAMERICAN EAGLE INSTRUMENTS, INC.KCX2026-06-26
00841013124723MicroquoreAMERICAN EAGLE INSTRUMENTS, INC.KCX2026-06-26
06974456210518CICADAFoshan Cicada Dental Instrument Co., Ltd.KCX2024-08-10
G443CSC2311Bracket Tweezer with SlotCHURAHI SURGICAL CO.KCX2023-08-08
G443CSC2321Bracket Tweezer Tube HoldingCHURAHI SURGICAL CO.KCX2023-08-08
G443CSC2331Bracket Tweezer small PointCHURAHI SURGICAL CO.KCX2023-08-08
00810072350831TweezersCole Instruments IncKCX2021-12-14
00810042120464DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
00810042120471DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
00810042120488DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
00810042120235DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
00810042120242DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
00810042120259DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
00810042120266DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
00810042120273DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21