FDA.reportPublic FDA data

Apilus

Primary DI
00686209051212
Brand
Apilus
Company
Dectro International
Model
Electropil
Catalog number
01-1210
Device description
needle-type epilator
Published
2026-05-12
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00686209051212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00686209051212006862090512126862090512120686209051212

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.

Regulatory Flags#

DUNS number
246237945
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00686209052011Pro-TecIsoGard F105-02012024-10-09
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
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
00686209052011Pro-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