FDA.reportPublic FDA data

Pro-Tec

Primary DI
00686209052011
Brand
Pro-Tec
Company
Dectro International
Model
IsoGard F1
Catalog number
05-0201
Device description
Hair-removal electrolysis probe, single-use
Published
2024-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KCWEpilator, High Frequency, Needle-Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCWEpilator, High Frequency, Needle-TypeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00686209052011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00686209052011006862090520116862090520110686209052011

GMDN Terms#

Term, Definition table
TermDefinition
Hair-removal electrolysis system needle electrode, single-useA sterile device designed as a needle-shaped electrode used together with a hair-removal electrolysis system and used to destroy the dermal papilla (hair root) through application of an electric current from the parent device via the tip of this device that is inserted close to the hair shaft, under the skin, and into the dermal papilla. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
246237945
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00686209051212ApilusElectropil01-12102026-05-12
00686209051014Pro-TecStainless Steel F105-01012024-10-09
00686209051021Pro-TecStainless Steel F205-01022024-10-09
00686209051038Pro-TecStainless Steel F305-01032024-10-09
00686209051045Pro-TecStainless Steel F405-01042024-10-09
00686209051052Pro-TecStainless Steel F505-01052024-10-09
00686209052028Pro-TecIsoGard F205-02022024-10-09
00686209052035Pro-TecIsoGard F305-02032024-10-09
00686209052042Pro-TecIsoGard F405-02042024-10-09
00686209052059Pro-TecIsoGard F505-02052024-10-09
00686209052110Pro-TecIsoBlend F105-02112024-10-09
00686209052127Pro-TecIsoBlend F205-02122024-10-09
00686209052134Pro-TecIsoBlend F305-02132024-10-09
00686209052141Pro-TecIsoBlend F405-02142024-10-09
00686209052158Pro-TecIsoBlend F505-02152024-10-09
00686209100903ApilusCLEO FLASH 12801-0090US2024-05-23
00686209100910ApilusCLEO BLEND 25601-0091US 2024-05-23
00686209101115ApilusJunior01-0111US2024-05-23
00686209106004Apilusxcell Pur01-0600US2024-05-23
00686209106059Apilusxcell Pro01-0605US2024-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00686209051212ApilusDectro InternationalKCW2026-05-12
00667259003963EVOLUTION XHDSilhouet-Tone CorporationKCW2025-07-09
00667259003970EVOLUTION ST350Silhouet-Tone CorporationKCW2025-07-09
08800016903317Secret RF Smartcure Applicator With ElectrodesCLASSYS Inc.KCW2024-10-30
00686209051014Pro-TecDectro InternationalKCW2024-10-09
00686209051021Pro-TecDectro InternationalKCW2024-10-09
00686209051038Pro-TecDectro InternationalKCW2024-10-09
00686209051045Pro-TecDectro InternationalKCW2024-10-09
00686209051052Pro-TecDectro InternationalKCW2024-10-09
00686209052028Pro-TecDectro InternationalKCW2024-10-09
00686209052035Pro-TecDectro InternationalKCW2024-10-09
00686209052042Pro-TecDectro InternationalKCW2024-10-09
00686209052059Pro-TecDectro InternationalKCW2024-10-09
00686209052110Pro-TecDectro InternationalKCW2024-10-09
00686209052127Pro-TecDectro InternationalKCW2024-10-09
00686209052134Pro-TecDectro InternationalKCW2024-10-09
00686209052141Pro-TecDectro InternationalKCW2024-10-09
00686209052158Pro-TecDectro InternationalKCW2024-10-09
00686209100903ApilusDectro InternationalKCW2024-05-23
00686209100910ApilusDectro InternationalKCW2024-05-23
00686209101115ApilusDectro InternationalKCW2024-05-23
00686209106004ApilusDectro InternationalKCW2024-05-23
00686209106059ApilusDectro InternationalKCW2024-05-23
00686209101238ApilusDectro InternationalKCW2024-05-22
00850057194005Elegance+Clareblend, Inc.KCW2023-12-14
00850057194036EleganceClareblend, Inc.KCW2023-12-14
00850057194043G-TechClareblend, Inc.KCW2023-12-14
00850057194050EssenceClareblend, Inc.KCW2023-12-14
00850057194067EZ3Clareblend, Inc.KCW2023-12-14
00850057194074LamprobeClareblend, Inc.KCW2023-12-14