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U.S. Department of Health and Human Services

Class 2 Device Recall Candela Laser

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 Class 2 Recall
Candela Laser
see related information
Date Posted November 18, 2013
Recall Status1 Terminated on June 08, 2015
Recall Number Z-0348-2014
Recall Event ID 66773
Premarket Notification
510(K) Numbers
K024260  K024335  K024371  K111144  K972767  K974381 
K981351  K994260 
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/
Candela Corporation
530 Boston Post Rd
Wayland, Massachusetts 01778-1833
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
DESIGN: 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 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 = CANDELA CORP.