Reported Jul 3, 2013 · Terminated

Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General…

ConBio, a CynoSure Company

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: ConBio, a CynoSure Company · 47733 Fremont Blvd · Fremont, CA · 94538-6512

Is this the product you have?

  • Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser
  • Manufactured byConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538
Lot codes and dates
  • 659-1050-585 nm Handpiece
  • Manufacturer numbers659-1050 / C13B1141 659-1050 / D13C1151 659-1050 / D13C1157 659-1050 / D13C1158 659-1050 / D13C1160 659-1050 / D13C1154 Model 659-1100 - 650 nm Handpiece
  • manufacturer numbers659-1100 / C13B1141 659-1100 / D13C1151 659-1100 / D13C1157 659-1100 / D13C1158 659-1100 / D13C1160 659-1100 / D13D1165
Amount recalled
12 (6 of model 659-1050; 6 of model 659-1100)

Where it was sold

Why it was recalled

An inconsistency was identified related to electronic display identification of the optional Multilite Dye Handpieces of the RevLite SI Laser system that may confuse user.

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 Jun 26, 2013 · Data as of Sep 19, 4:49 PM UTC

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