VIVACE ULTRA ABMVIVM03

GUDID G055ABMVIVM030

10 CUSTOM INSULATED MICRONEEDLE CARTRIDGES FOR SMALL AREAS CONCENTRATED TREATMENTS

Aesthetics Biomedical, Inc.

Intradermal radio-frequency ablation system needle electrode

• Primary Device ID: G055ABMVIVM030
• NIH Device Record Key: 813c6dbb-a110-46c9-8e3d-60f064ac003e
• Commercial Distribution Discontinuation: 2025-05-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VIVACE ULTRA
• Version Model Number: VERSION 1.0
• Catalog Number: ABMVIVM03
• Company DUNS: 033599752
• Company Name: Aesthetics Biomedical, Inc.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G055ABMVIVM030 [Unit of Use]
HIBCC	G055ABMVIVM031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221574

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-05-07
• Device Publish Date: 2022-12-30

On-Brand Devices [VIVACE ULTRA]

• G055ABMVIVS020: ELECTROSURGICAL DEVICE WITHOUT ULTRASOUND MEANT FOR ELECTROCOAGULATION AND HEMOSTASIS IN DERMATO
• G055ABMVIVS010: ELECTROSURGICAL DEVICE WITH OR WITHOUT ULTRASOUND MEANT FOR ELECTROCOAGULATION AND HEMOSTASIS IN
• G055ABMVIVM120: 10 CARTRIDGES CONTAINING 60 NON-INSULATED MICRONEEDLES IN A SQUARE PATTERN
• G055ABMVIVM110: 10 CARTRIDGES CONTAINING 60 INSULATED MICRONEEDLES IN A SQUARE PATTERN
• G055ABMVIVM080: 10 STANDARD NON-INSULATED MICRONEEDLE CARTIDGES
• G055ABMVIVM070: 10 STANDARD INSULATED MICRONEEDLE CARTIDGES
• G055ABMVIVM040: 10 CUSTOM NON-INSULATED MICRONEEDLE CARTRIDGES FOR SMALL AREAS CONCENTRATED TREATMENTS
• G055ABMVIVM030: 10 CUSTOM INSULATED MICRONEEDLE CARTRIDGES FOR SMALL AREAS CONCENTRATED TREATMENTS
• G055ABMVIVR010: RADIOFREQUENCY APPLICATOR, INTERFACE BETWEEN CART AND MICRONEEDLE CARTRIDGE
• G055ABMVIVM100: A CARTRIDGE CONTAINING 60 NON-INSULATED MICRONEEDLES IN A SQUARE PATTERN
• G055ABMVIVM090: A CARTRIDGE CONTAINING 60 INSULATED MICRONEEDLES IN A SQUARE PATTERN
• G055ABMVIVM060: INDIVIDUAL STANDARD NON-INSULATED MICRONEEDLE CARTIDGE
• G055ABMVIVM050: INDIVIDUAL STANDARD INSULATED MICRONEEDLE CARTIDGE
• G055ABMVIVM020: CUSTOM NON-INSULATED MICRONEEDLE CARTRIDGE FOR SMALL AREAS CONCENTRATED TREATMENTS
• G055ABMVIVM010: CUSTOM INSULATED MICRONEEDLE CARTRIDGE FOR SMALL AREAS CONCENTRATED TREATMENTS