Z-1599-2013Class II

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

Name: Z-1599-2013 Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for...
Creator: ConBio, a CynoSure Company
Published: 2013-05-09
License: https://open.fda.gov/license/

ConBio, a CynoSure Company / initiated 2013-05-09 / Terminated / root cause: manufacturing process

FDA source

ConBio, a CynoSure Company began a recall of Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General... on 2013-05-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1599-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-09
Posted: 2013-06-26
Terminated: 2013-06-26
Recalling firm: ConBio, a CynoSure Company
Product: 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 by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Cynosure Inc., sent a "MEDICAL DEVICE FIELD ACTIONS NOTIFICATION" letter dated May 9, 2013 to its customers via UPS next day. The letter described the product, problem and actions to be taken. The customers were instructed to immediately stop using the Revlite SI Multilite Dye Handpieces upon receipt of this letter and complete and return the enclosed Field Corrective Action Acknowledgement Form via e-mail to: [email protected] or FAX to: 978-256-6556. A Cynosure representative will be contacting customers to schedule and arrange an exchange of the affected handpieces. If additional information is required please contact VP of Regulatory Affairs and Quality Systems at 978-367-2350 or via email at [email protected].
Quantity in commerce: 12 (6 of model 659-1050; 6 of model 659-1100)
Distribution: Worldwide distribution: USA (nationwide) including states of: IL, ME, NM and VA; and countries of: Australia and Chile.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1599-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1599-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-26

Product code GEX

K103118Class IIRevlite Q-Switched Nd: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. / cleared 2010-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)