FDA.reportPublic FDA data

VIVACE ULTRA

Primary DI
G055ABMVIVM100
Brand
VIVACE ULTRA
Company
Aesthetics Biomedical, Inc.
Model
VERSION 1.0
Catalog number
ABMVIVM10
Device description
A CARTRIDGE CONTAINING 60 NON-INSULATED MICRONEEDLES IN A SQUARE PATTERN
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
G055ABMVIVM100PrimaryHIBCC0

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
G055ABMVIVM010VIVACE ULTRAVERSION 1.0ABMVIVM012022-12-30
G055ABMVIVM020VIVACE ULTRAVERSION 1.0ABMVIVM022022-12-30
G055ABMVIVM050VIVACE ULTRAVERSION 1.0ABMVIVM052022-12-30
G055ABMVIVM060VIVACE ULTRAVERSION 1.0ABMVIVM062022-12-30
G055ABMVIVM090VIVACE ULTRAVERSION 1.0ABMVIVM092022-12-30
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
10884521783829LigaSureCovidien LPGEI2026-10-23
00190776436858MillenniumAvalign Technologies, Inc.GEI2026-10-22
03770033463055FETOLYDIAGNOLYIYO2026-10-22
B382SD77105560Surgical DirectSurgical Direct, Inc.GEI2026-10-22
00190776435752MillenniumAvalign Technologies, Inc.GEI2026-10-21
00190776435769MillenniumAvalign Technologies, Inc.GEI2026-10-21
00841019124192KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-21
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16