FDA.reportPublic FDA data

Essence

Primary DI
00850057194050
Brand
Essence
Company
Clareblend, Inc.
Model
2016-01U
Device description
Electrology Hair Removal (Needle Epilation)
Published
2023-12-14
Public version status
New
Distribution status
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
00850057194050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057194050008500571940508500571940500850057194050

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
139701114
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850057194005Elegance+2014-10U2023-12-14
00850057194036Elegance2007-05U2023-12-14
00850057194043G-Tech2021-GT2023-12-14
00850057194067EZ32018-01U2023-12-14
00850057194074Lamprobe7100-LP2023-12-14
00850057194081Skin Classic2016-50252023-12-14
00850057194098Thermoclear2018-04CL2023-12-14
00850057194104Thermoclear Pro2018-04CLP2023-12-14
00850057194111Elite2022-EL2023-12-14
00850057194135Epic4413-EP012023-12-14
00850057194012Jeunesse Pro2006-03U2023-12-12
00850057194029Jeunesse Mini2014-HHV32023-12-12
00850057194128Jeunesse Petite2021-JP2023-12-12

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
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
00850057194067EZ3Clareblend, Inc.KCW2023-12-14
00850057194074LamprobeClareblend, Inc.KCW2023-12-14