FDA.reportPublic FDA data

SKINEXIANS

Primary DI
03760394190004
Brand
SKINEXIANS
Company
SKINEXIANS
Model
FULLSKIN V7
Catalog number
65.011
Device description
110V therapeutic massager device for aesthetic purposes including all the accessories for its marketing and use.
Published
2024-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
03760394190004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760394190004037603941900043760394190004

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum suction body contouring systemAn electrically-powered assembly of noninvasive devices intended primarily for the temporarily reduction in the appearance of cellulite through the application of suction forces to the skin surface. It includes a motorized vacuum pump, a control unit, and one or more hand-held skin-surface applicators (cups). The system may in addition be used to improve skin appearance by smoothing wrinkles, tightening muscle/connective tissue, and/or improving lymphatic drainage; it may also be used as a massager to treat minor muscle pain. It is intended to be operated by a trained professional.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pressure880millibar

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6789088180jay@mansourconsulting.com

Regulatory Flags#

DUNS number
276134694
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810140063045RENPHO Eye MassagerJoicom CorporationISA2026-05-26
06975617995039SLIMMING TREATMENT DEVICEBEIJING HONKON TECHNOLOGIES CO., LTD.ISA2026-03-23
04055207069226NARichard Wolf GmbHISA2026-03-12
04055207069257NARichard Wolf GmbHISA2026-03-12
08809439110623WITHNIXWITHNIX CO.,LTDISA2026-03-06
08809439110630WITHNIXWITHNIX CO.,LTDISA2026-03-06
07630039101909MASTERPULS®Storz Medical AGISA2026-03-01
08057592610676IcooneI-TECH INDUSTRIES SRLISA2026-02-19
08800250280694QuadtheraECO DM LAB Co., Ltd.ISA2026-02-16
06973134771549silverfoxSilverfox Corporation LimitedISA2026-02-05
00851439007135PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007142PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007159PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007166PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007173PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007180PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007197PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007203PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00031262120243HomedicsHealth Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.ISA2026-01-15
08806109104555Centellian24 MADECA PRIME RITUAL WHITE PEARLDongkook Pharmaceutical Co.,Ltd.ISA2026-01-13
08806109105422Centellian24 MADECA PRIME MAXDongkook Pharmaceutical Co.,Ltd.ISA2026-01-13
10810140062892RENPHOJoicom CorporationISA2026-01-04
10810140062861RENPHOJoicom CorporationISA2025-12-16
08436560853152ToskaniTOSKANI SL.ISA2025-12-12
08436560853169ToskaniTOSKANI SL.ISA2025-12-12
10810140062854RENPHOJoicom CorporationISA2025-12-03
06970441320132AquafirmeXSBeijing Anchorfree Technology Co., Ltd.ISA2025-09-23
05391540830833Préime DermaFacialEMA AESTHETICS LIMITEDISA2025-09-15
10810140062670RENPHOJoicom CorporationISA2025-09-11
00860010877487WavonEase Seating SystemsISA2025-09-08