Multilite Dye Handpieces, accessory of the RevLite SI Laser

Product Description:

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. The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538

Reason for Recall:  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.

Product Quantity: 12 (6 of model 659-1050; 6 of model 659-1100)

Code Information:

659-1050-585 nm Handpiece; Manufacturer numbers: 659-1050 / C13B1141 659-1050 / D13C1151 659-1050 / D13C1157 659-1050 / D13C1158 659-1050 / D13C1160 659-1050 / D13C1154 Model 659-1100 – 650 nm Handpiece; manufacturer numbers: 659-1100 / C13B1141 659-1100 / D13C1151 659-1100 / D13C1157 659-1100 / D13C1158 659-1100 / D13C1160 659-1100 / D13D1165.

Recalling Firm:

ConBio, a CynoSure Company
47733 Fremont Blvd
Fremont, CA 94538-6512
United States

Recall Initiation Date: 5/9/2013

Full Details: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=118789