![]() Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.ĥ10(K)s with Product Code = GEX and Original Applicant = CANDELA CORP. ![]() 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. 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.ġ A record in this database is created when a firm initiates a correction or removal action. The CANDELA GentleLase Pro U Plus combines speed, comfort, and long lasting results The CANDELA GentleLase Pro U Plus works on any area of the body where a hair- free appearance is desired Shaving, waxing and depilatory creams remove the hair but leave the hair follicles intact, so the hair regrows within one to four weeks in most cases. A software update to Version 2.0 will be issued to the user by a field service representative. Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.Ĭandela 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. Powered Laser Surgical Instrument - Product Code GEXĬandela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 15.
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