America Cryo SubZero

Local cryotherapy/contouring · Electric localized cryotherapy + cryo facials

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What it's actually cleared for: No cryolipolysis 510(k) — the OOK product-code list contains only Zeltiq/CoolSculpting devices

Last verified: August 6, 2026 · How we verify

New: $15k–$30k|Used: market estimate, no email required

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Overview

Spa-channel localized cryo slimming/facial unit

FDA & regulatory status

No US clearance on file

What it's actually cleared for:

No cryolipolysis 510(k) — the OOK product-code list contains only Zeltiq/CoolSculpting devices

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

Economics data for this platform hasn't been published yet.

Chains using this device

No confirmed chain deployments recorded yet.

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History

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

  1. August 5, 2026

    FDA status

    UnknownNot-US-Cleared

    Source: Automatic record update

  2. August 5, 2026

    FDA indication

    No cryolipolysis 510(k) — the OOK product-code list contains only Zeltiq/CoolSculpting devices

    Source: Automatic record update

  3. August 1, 2026

    Record created

    Added to The Aesthetic Index — August 2026

    Source: The Aesthetic Index editorial

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