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
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00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
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07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.OUH2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092893ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092909ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092916ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092954ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28