Candela Frax Pro (Nordlys)

Non-Ablative Fractional · 1550nm + 1940nm fractional

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What it's actually cleared for: Frax 1550/1940 fractional laser resurfacing modules; SWT IPL under Ellipse-era clearances

Last verified: August 6, 2026 · How we verify

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Overview

Dual-depth fractional on Nordlys platform

FDA & regulatory status

Cleared via 510(k)

What it's actually cleared for:

Frax 1550/1940 fractional laser resurfacing modules; SWT IPL under Ellipse-era clearances

510(k) numbers

K161162; K192951; K212492

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.

Owner reviews

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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

    K212492K161162; K192951; K212492

    Source: Automatic record update

  2. August 5, 2026

    FDA indication

    1550/1940nm non-ablative fractional resurfacingFrax 1550/1940 fractional laser resurfacing modules; SWT IPL under Ellipse-era clearances

    Source: Automatic record update

  3. August 5, 2026

    FDA status

    UnknownCleared

    Source: Automatic record update

  4. August 5, 2026

    FDA K-numbers

    K212492

    Source: Automatic record update

  5. August 5, 2026

    FDA indication

    1550/1940nm non-ablative fractional resurfacing

    Source: Automatic record update

  6. August 1, 2026

    Record created

    Added to The Aesthetic Index — August 2026

    Source: The Aesthetic Index editorial

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