Reported May 25, 2016 · Terminated

Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).

Lumenis Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lumenis Ltd · 13 Hayetzira St.,Yokneam Ind. Park · Yokneam, N/A · N/A

Is this the product you have?

  • Lumenis M22 System Model NumberGA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971)
Lot codes and dates
  • Lumenis M22 System Model NumberGA-0005400 (M22 IPL + YAG Module) All Acne Filters
  • manufactured and Distributed BetweenAugust 04 2015 and November 06 2015
Amount recalled
33 filters

Where it was sold

Why it was recalled

Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 30, 2016 · Data as of Sep 19, 5:20 PM UTC

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