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U.S. Department of Health and Human Services

Class 2 Device Recall Candela Laser

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  Class 2 Device Recall Candela Laser see related information
Date Initiated by Firm November 06, 2013
Date Posted November 18, 2013
Recall Status1 Terminated 3 on June 08, 2015
Recall Number Z-0348-2014
Recall Event ID 66773
510(K)Number K972767  K024260  K024335  
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015.
and Candela Laser GentleLase Pro LE,
Model number: 9914-00-9040
Code Information GL Pro Model 9914-00-9015:: SN 9914-9015-0005 through 9914-9015-1259 GL Pro LE Model 9914-00-9040: SN 9914-9040-0716 through 9914-9040-1214 
Recalling Firm/
Manufacturer		 Candela Corporation
530 Boston Post Rd
Wayland MA 01778-1833
For Additional Information Contact
508-358-7400
Manufacturer Reason
for Recall		 Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
FDA Determined
Cause 2		 Software design
Action Candela notiifed Distributors on 11/8/13 through e-mail, Certified return receipt request, or FedEx package containing distributor letter, customer letter for translation and customer lists. A software update to Version 2.0 will be issued to the user by a field service representative.
Quantity in Commerce 1258 units
Distribution Worldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = CANDELA CORP.
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