8/16/2023 0 Comments Candela laser cryogen![]() No Downtime for Laser Procedures – The Candela GentleYAG Cosmetic Laser is the only 1064 nm laser that uses the Dynamic Cooling Device to protect and cool the skin during the laser procedure. Treats All Skin Types – The GentleYAG ideal for all skin types because of the deep penetration with minimal scattering of laser energy, especially for dark and tanned skin. The Candela GentleYAG Cosmetic Laser is versatile, fast, powerful. Treatment Versatility – The wide selection of spot sizes, variable pulse duration and range of fluence allows the GentleYAG to: remove hair reduce fine lines and wrinkles erase leg veins and facial veins and rejuvenate the skin. Hair removal energies in 3 ms pulse durations for unparalleled treatment efficacies, especially on fine hair. Powerful – The peak power is 26,3 kW and able to deliver fluences up to 600 J/cm2 for vascular applications. ![]() Additionally, the GentleYAG has the largest spot size comparing to other Nd:YAG lasers in the industry, and has the capability of delivering fluences up to 600 J/cm2 for vascular applications. Candela GentleYAG Cosmetic Laser ApplicationsĬandela GentleYAG Cosmetic Laser Featuresįast – Using the unique 18 mm spot size and the 2 Hz repetition rate, the Candela GentleYAG Cosmetic Laser provides fast treatment with a lower amount of laser pulses. The Candela GentleYAG Cosmetic Laser is available in many configurations, including the GentleYAG HR, GentleYAG SRT, and GentleYAG VR. It features a spot size of up to 18mm and 26,333 watts of power, so you can treat patients faster and more efficiently. Using Candela’s exclusive cryogen DCD cooling system, this machine produces incredibly fast and effective results while at the same time maximizing patient comfort. 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.Introducing the Candela GentleYAG Cosmetic Laser System. ![]() 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. The completed form must be scaģ86 cases ( 15 pack canister/ case) (216 additional cases as of 12/09/19)ġ A record in this database is created when a firm initiates a correction or removal action. Please complete and return the enclosed ͊cknowledgement Form - GentleCool Pro Canister Recall. To safely and efficiently implement this recall, we are asking that you please take the following actions:ģ. The reason for this expanded recall is unchanged from the initial communications sent.Īctions to Be Taken by the Customer/User: Thus, we are updating this notice to make you aware of these additional lots. Twenty additional lots have now been identified (listed in bold on the following page), since the initial notification was sent mid-September. 0, M-F 8:30 am 8 pm EST, or reach them via email at Urgent Medical Device Expanded Recall notification letter dated 12/6/19 was sent to customers. If you have any questions, please do not hesitate to call our Customer Service team at 80 ext. Information regarding retrieval of your affected inventory will be forthcoming from Candela Medical. 0 to make arrangements for replacement of your affected inventory.Ħ. Please contact Candela Customer Service at 80 ext. Your communication should include a copy of this recall notification letter.ĥ. If you may have further distributed this product, please identify those locations and notify them at once of this product recall. ![]() ![]() The completed form must be scanned and emailed to within 24 hours.Ĥ. Immediately discontinue use and distribution of the identified lots of the GentleCool Pro Cryogen Canister.ģ. Immediately examine your inventory and quarantine the identified lots of the GentleCool Pro Cryogen Canister.Ģ. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modulesġ. The canister neck bushing may become loose and separate from the body of the canister during use. Powered laser surgical instrument - Product Code GEXĬoolant canister for use with surgical laser. ![]()
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