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Vivace Ultra

FDA UDI

Class II (US FDA UDI)

by Aesthetics Biomedical

Identity

Trade Name
VIVACE ULTRA FDA UDI
Generic Name
Intradermal radio-frequency ablation system needle electrode FDA UDI
Device Name
CUSTOM NON-INSULATED MICRONEEDLE CARTRIDGE FOR SMALL AREAS CONCENTRATED TREATMENTS FDA UDI
Model / Reference
VERSION 1.0 FDA UDI
Description
CUSTOM NON-INSULATED MICRONEEDLE CARTRIDGE FOR SMALL AREAS CONCENTRATED TREATMENTS FDA UDI

Identifiers

Catalog Number
ABMVIVM02 FDA UDI
Primary DI / UDI-DI
G055ABMVIVM020 FDA UDI
510(k) Number
K221574 FDA UDI
FDA Product Code
GEI FDA UDI
OUH FDA UDI
IYO FDA UDI
GMDN Term
Intradermal radio-frequency ablation system needle electrode FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
892.1560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intradermal radio-frequency ablation system needle electrode

Vivace Ultra by Aesthetics Biomedical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intradermal radio-frequency ablation system needle electrode.

Cleared under the same submission

K221574 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aesthetics Biomedical

Sources (1)

  • FDA UDI 30291d38-802b-4620-9884-72524bb8f32b 35 fields · synced Jun 1, 2026