FDA.reportPublic FDA data

VIVACE ULTRA

Primary DI
G055ABMVIVM010
Brand
VIVACE ULTRA
Company
Aesthetics Biomedical, Inc.
Model
VERSION 1.0
Catalog number
ABMVIVM01
Device description
CUSTOM INSULATED MICRONEEDLE CARTRIDGE FOR SMALL AREAS CONCENTRATED TREATMENTS
Published
2022-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
OUHSkin Resurfacing Rf Applicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
OUHSkin Resurfacing Rf ApplicatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221574000LUDWIG Electrosurgical DeviceAesthetics Biomedical2022-10-16GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G055ABMVIVM010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intradermal radio-frequency ablation system needle electrodeAn electrical conductor intended to be introduced into the dermal layer of the skin (intradermal) to deliver radio-frequency (RF) current in a monopolar configuration for coagulation/ablation, to treat skin conditions [typically superficial skin lesions (e.g., telangiectasia, cherry angioma, venous lake, skin tags) and/or acne]. It is intended to be used in conjunction with an appropriate RF generator and attached to a probe handle (not included). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033599752
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G055ABMVIVS020VIVACE ULTRAVERSION 1.0ABMVIVS022022-12-30
G055ABMVIVM031VIVACE ULTRAVERSION 1.0ABMVIVM032022-12-30
G055ABMVIVM041VIVACE ULTRAVERSION 1.0ABMVIVM042022-12-30
G055ABMVIVM071VIVACE ULTRAVERSION 1.0ABMVIVM072022-12-30
G055ABMVIVM081VIVACE ULTRAVERSION 1.0ABMVIVM082022-12-30
G055ABMVIVM111VIVACE ULTRAVERSION 1.0ABMVIVM112022-12-30
G055ABMVIVM121VIVACE ULTRAVERSION 1.0ABMVIVM122022-12-30
G055ABMVIVU010VIVACE ULTRAVERSION 1.0ABMVIVU012022-12-30
G055ABMVIVM020VIVACE ULTRAVERSION 1.0ABMVIVM022022-12-30
G055ABMVIVM050VIVACE ULTRAVERSION 1.0ABMVIVM052022-12-30
G055ABMVIVM060VIVACE ULTRAVERSION 1.0ABMVIVM062022-12-30
G055ABMVIVM090VIVACE ULTRAVERSION 1.0ABMVIVM092022-12-30
G055ABMVIVM100VIVACE ULTRAVERSION 1.0ABMVIVM102022-12-30
G055ABMVIVR010VIVACE ULTRAVERSION 1.0ABMVIVR012022-12-30
G055ABMVIVS010VIVACE ULTRAVERSION 1.0ABMVIVS012022-12-30
G055ABMVIVM030VIVACE ULTRAVERSION 1.0ABMVIVM032022-12-30
G055ABMVIVM040VIVACE ULTRAVERSION 1.0ABMVIVM042022-12-30
G055ABMVIVM070VIVACE ULTRAVERSION 1.0ABMVIVM072022-12-30
G055ABMVIVM080VIVACE ULTRAVERSION 1.0ABMVIVM082022-12-30
G055ABMVIVM110VIVACE ULTRAVERSION 1.0ABMVIVM112022-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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