FDA.reportPublic FDA data

Jeunesse Pro

Primary DI
00850057194012
Brand
Jeunesse Pro
Company
Clareblend, Inc.
Model
2006-03U
Device description
Electric Skin Massage
Published
2023-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISAMassager, therapeutic, electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850057194012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057194012008500571940128500571940120850057194012

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemAn electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

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
00850057194050Essence2016-01U2023-12-14
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
00850057194029Jeunesse Mini2014-HHV32023-12-12
00850057194128Jeunesse Petite2021-JP2023-12-12

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