Aesthetics Biomedical (Cartessa) Vivace Ultra

RF Microneedling · RF microneedling + ultrasound skin visualization

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What it's actually cleared for: RF microneedling (cleared under trade name LUDWIG, 2022)

Last verified: August 6, 2026 · How we verify

New: $60k–$90k|Used: market estimate, no email required

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Bottom line

The precision-and-comfort play: the first RF microneedling platform with built-in ultrasound visualization, letting providers map skin thickness before setting needle depth instead of guessing from a chart. Combined with the gold-needle comfort reputation of the original Vivace, it's the strongest luxury-experience RF-MN device. Trade-offs: Aesthetics Biomedical is a small Phoenix company without Cynosure/InMode-scale sales and service infrastructure, and consumer search volume is a fraction of Morpheus8's.

Overview

First RF-MN with built-in ultrasound imaging

How it works

The science

Insulated microneedles fire RF into the dermis to heat tissue, contract collagen, and trigger remodeling for wrinkles, laxity, scars, texture. The Ultra's headline: a linear-array ultrasound in the workflow images skin before treatment so depth settings match actual tissue thickness by area — meaningful on thin-skinned zones like periorbital and neck where fixed-depth protocols over- or under-treat. Retains the Vivace formula: 36-needle gold-tipped array with precision robotic insertion (the comfort reputation), depths to ~3.5mm, red/blue LED modes, and the branded Vivace Experience serum + cooling peptide mask protocol.

Patented tech

The ultrasound visualization system is the genuinely novel piece — imaging-guided depth selection no other US RF-MN platform ships (FDA-cleared via the ASCA pathway). The gold-plated robotic insertion tip is refinement, and the reason for the comfort claims.

Origin

Phoenix, AZ brand owner/developer; manufacturing follows the Korean-OEM pattern common to the Vivace line — verify current arrangement.

FDA & regulatory status

Cleared via 510(k)

What it's actually cleared for:

RF microneedling (cleared under trade name LUDWIG, 2022)

510(k) numbers

K221574

Regulatory data is compiled from public FDA 510(k) records and may lag recent clearances. Always confirm status with the manufacturer before purchase.

Treatment economics

What practices charge

~$850-1,300 per session, at or slightly above Morpheus8 on the experience and imaging story; standard course 3 sessions 4-6 weeks apart, packaged ~$2,500-3,600 (competitive-market bundles ~$1,800-2,500).

Consumables & recurring cost

Single-use 36-needle tips plus branded serum/peptide-mask kits — roughly ~$100-200 per treatment all-in (verify pricing and minimums). The Experience layer is margin-friendly but adds per-treatment cost most competitors don't carry.

Ideal for

Best-fit practice

Upscale medspas and plastic-surgery-adjacent practices selling comfort, precision, and premium experience to patients 35-60 — especially markets saturated with discounted Morpheus8. Less suited to volume shops: imaging adds treatment time and the brand won't generate inbound demand on its own.

Compliance

Medical director & delegation

Class II device requiring medical direction; typical arrangement is physician oversight with delegation to NPs, PAs, or RNs where allowed — estheticians generally can't fire it. The ultrasound step raises training expectations.

Contraindications & screening

Pacemakers/ICDs and implanted electronics, pregnancy, active infection or inflammatory skin disease, recent isotretinoin, keloid history, metal implants near the zone. Gold-needle allergy is rare but belongs on the intake form.

Ownership

Warranty & service

~1-year warranty; extended plans through Aesthetics Biomedical — a small-company service network, so nail down loaner policy and response times in the purchase agreement. Downtime hurts more when the manufacturer has no regional depot.

Resale & used market

Original Vivace trades steadily at ~$15k-30k; the Ultra is too new for a deep used market, and small-brand devices historically depreciate faster than InMode/Cynosure equivalents. Buy for use, not exit value.

Chains using this device

No confirmed chain deployments recorded yet.

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InMode Fractora

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History

Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.

  1. August 5, 2026

    FDA K-numbers

    K221574; K150409K221574

    Source: Automatic record update

  2. August 5, 2026

    FDA indication

    RF microneedling with ultrasound skin visualization cleared for tissue coagulation (cleared under trade name LUDWIG)RF microneedling (cleared under trade name LUDWIG, 2022)

    Source: Automatic record update

  3. August 5, 2026

    FDA K-numbers

    K221574K221574; K150409

    Source: Automatic record update

  4. August 5, 2026

    FDA indication

    RF microneedling (cleared under trade name LUDWIG, 2022)RF microneedling with ultrasound skin visualization cleared for tissue coagulation (cleared under trade name LUDWIG)

    Source: Automatic record update

  5. August 5, 2026

    FDA K-numbers

    K221574; K150409K221574

    Source: Automatic record update

  6. August 5, 2026

    FDA indication

    RF microneedling with ultrasound skin visualization cleared for tissue coagulation (cleared under trade name LUDWIG)RF microneedling (cleared under trade name LUDWIG, 2022)

    Source: Automatic record update

  7. August 1, 2026

    Record created

    Added to The Aesthetic Index — August 2026

    Source: The Aesthetic Index editorial

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