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U.S. Department of Health and Human Services

Class 2 Device Recall RevLite SI Laser

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 Class 2 Recall
RevLite SI Laser
see related information
Date Posted June 26, 2013
Recall Status1 Terminated on June 26, 2013
Recall Number Z-1599-2013
Recall Event ID 65407
Premarket Notification
510(K) Number
K103118 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
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
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/
Manufacturer
ConBio, a CynoSure Company
47733 Fremont Blvd
Fremont, California 94538-6512
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Irina Kulinets, Ph.D.
978-367-2350
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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: mflynn@cynosure.com 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 ikulinets@cynosure.com.
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.
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) Database 510(K)s with Product Code = GEX and Original Applicant = HOYA PHOTONICS, INC.
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