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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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088095244976843H Smart Massage Bed3H, Co., LtdISA2026-07-29
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088095244977143H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977213H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977383H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977453H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977523H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244976773H Smart Massage Bed3H, Co., LtdISA2026-07-28
00810140063106Renpho Massage GunJoicom CorporationISA2026-07-21
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06972433811246JermeiShenzhen Jermei Medical Device Technology Co.,LtdISA2026-06-10
00850071298017Smart-RSTHyperion Medical Technologies, Inc.ISA2026-06-02
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08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
00810140061355RENPHOJoicom CorporationISA2024-11-19
00810140061362RENPHOJoicom CorporationISA2024-11-19
00074108453488CONAIRCONAIR CORPORATIONISA2024-10-07