||June 26, 2013
||Terminated on June 26, 2013
|Recall Event ID
Powered laser surgical instrument -
||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.
ConBio, A Cynosure Company
47733 Fremont blvd
Fremont, CA 94538
||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.
ConBio, a CynoSure Company
47733 Fremont Blvd
|For Additional Information Contact
||Irina Kulinets, Ph.D.
|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.
||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: firstname.lastname@example.org 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@example.com.
|Quantity in Commerce
||12 (6 of model 659-1050; 6 of model 659-1100)
||Worldwide distribution: USA (nationwide) including states of: IL, ME, NM and VA; and countries of: Australia and Chile.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = GEX and Original Applicant = HOYA PHOTONICS, INC.