Osnovna verzija ovog sistma koja koristi Alexandrite (755nm), a. Brz je, pouzdan i pun naprednih funkcija koje nude izvanredne rezultate i koje su stekle poverenje korisnika irom sveta. 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. At Sanova Dermatology, the revolutionary Candela ® GentleYag Pro-U is used to offer laser hair removal to a wider variety of patients. GentleLase Pro je vrhunski laser za estetsku industriju, idealno je reenje za uklanjanje dlaka, leenje pigmentnih lezija i leenje vaskularnih lezija. 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. Brand Name: GentleLASE Pro-U Version or Model: 30 Commercial Distribution Status: In Commercial Distribution Catalog Number. Background data: For non-thermal photorejuvenation, laser and LED light sources have been demonstrated to be safe and effective. Lasery Gentle Pro umoují krom epilace také oetit velké mnoství jiných indikací. Úspch postavený na dvou desetiletích inovací.Zlatý standard v laserovém odstraování chloupk. GentleMax PRO laser combines the fastest and most powerful GentleLase Pro Alexandrite laser (wavelength 755 nm) and GentleYAG Pro laser (wavelength 1064 nm). DEVICE: GentleLASE Pro-U (00817495020938) Download: XML JSON. Alexandrit laser pro epilaci a odstraování pigmentových a cévních lézí. A software update to Version 2.0 will be issued to the user by a field service representative. GentleMax Pro is the latest two-laser platform including a variety of treatment options, ranging from unwanted hair removal for all skin types to the treatment of pigment and vascular lesions. ![]() 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. ![]() It’s fast and loaded with advanced features that continue to deliver extraordinary results that have earned the trust of practitioners worldwide. GL Pro Model 15:: SN 9914-9015-0005 through 9914-9015-1259 GL Pro LE Model 40: SN 9914-9040-0716 through 9914-9040-1214 GentleLase Pro-U, the aesthetic industry’s premier laser, is an ideal solution for hair removal, treating pigmented lesions and the treatment of vascular lesions, such as port wine stains. Powered Laser Surgical Instrument - Product Code GEXĬandela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 15.
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