Recall Z-1599-2013— ConBio, a CynoSure Company

Name: FDA recall Z-1599-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-09

Class II · Terminated

Class II FDA medical device recall by ConBio, a CynoSure Company, initiated 2013-05-09, terminated 2013-06-26. It names one FDA 510(k) clearance: K103118. 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. Reason: 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..

Recalling firm: ConBio, a CynoSure Company
Classification: Class II
Status: Terminated
Initiated: 2013-05-09
Terminated: 2013-06-26
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K103118 — REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTORHoya Photonics, Inc.·cleared 2010-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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 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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.