FDA.reportPublic FDA data

VIVACE ULTRA

Primary DI
G055ABMVIVU010
Brand
VIVACE ULTRA
Company
Aesthetics Biomedical, Inc.
Model
VERSION 1.0
Catalog number
ABMVIVU01
Device description
ULTRASOUND TRANSDUCER GRIPPED BY THE USER DURING SCANNING PHASES
Published
2022-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G055ABMVIVU010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical ultrasound imaging transducerA hand-held ultrasound imaging transducer assembly designed to be positioned within a surgical site for localized intraoperative imaging applications. It is sometimes referred to as a surgical probe or fingertip probe. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. This group of devices includes ultrasound imaging transducer assemblies used with A-mode, B-mode, M-mode, Doppler, colour Doppler (CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This is a reusable device.

Regulatory Flags#

DUNS number
033599752
Device count
1
Lot or batch
true
Serial number
true
Manufacturing 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
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
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
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14