[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-239004-105":53,"doc-detail-239004-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","visumax-femtosecond-laser-system-summary-of-safety-and-effectiveness-data-ssed","VisuMax® Femtosecond Laser System - SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)","","This Summary of Safety and Effectiveness Data (SSED) describes the VisuMax® Femtosecond Laser (procode OTL) for refractive correction using the small incision lenticule extraction (SMILE) procedure. Indications cover myopia from ≥ -1.00 D to ≤ -8.00 D with specified cylinder and MRSE criteria in patients 22 years and older with stable manifest refraction over the prior year. Contraindications include insufficient residual stromal bed thickness, abnormal corneal topography, progressive/unstable myopia signs, severe dry eye, active infection/inflammation, recent herpes eye disease, autoimmune/connective tissue disease, uncontrolled diabetes, and uncontrolled glaucoma.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/visumax-femtosecond-laser-system-summary-of-safety-and-effectiveness-data-ssed/239004/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/visumax-femtosecond-laser-system-summary-of-safety-and-effectiveness-data-ssed/239004.png","ImageObject",442,249,{"name":88,"@type":89},"Aria Callaghan","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-23","2026-09-11",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",9,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What is the VisuMax® Femtosecond Laser used for in the SMILE procedure?","Question",{"text":109,"@type":110},"It is used in small incision lenticule extraction (SMILE) to reduce or eliminate myopia within the stated range, subject to the specified ocular measurement criteria and stability of manifest refraction over the past year.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"Which patients are contraindicated for VisuMax SMILE?",{"text":114,"@type":110},"Contraindications include too-thin residual stromal bed thickness, abnormal corneal topographic findings such as keratoconus, signs of progressive or unstable myopia, irregular corneal mires, severe dry eye, active eye infection or inflammation, recent herpes eye infection, autoimmune/connective tissue disease, uncontrolled diabetes, and uncontrolled glaucoma.",{"name":116,"@type":107,"acceptedAnswer":117},"Where can the warnings and precautions be found?",{"text":118,"@type":110},"The warnings and precautions are provided in the VisuMax® Femtosecond Laser labeling.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},239004,1790874595,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":42,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":8},962084926284,"https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0","SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)  \nI.  GENERAL INFORMATION  \nDevice Generic Name: Femtosecond Laser System for refractive correction  \nDevice Trade Name: VisuMax® Femtosecond Laser  \nDevice Procode: OTL  \nApplicant’s Name and Address: Carl Zeiss Meditec Inc.  \n5160 Hacienda Drive  \nDublin, California 94568 USA  \n(925) 557-4100  \nDate(s) of Panel Recommendation: None  \nPremarket Approval Application (PMA) Number: P150040  \nDate ofFDA Notice of Approval: September 13, 2016  \nII. INDICATIONS FOR USE  \nThe VisuMax® Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia ≥ -1.00 D to ≤ -8.00 D, with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D in the eye to be treated in patients who are  \n22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of ≤ 0.50 D MRSE.  \nIII.  CONTRAINDICATIONS  \nVisuMax SMILE procedure for the correction of myopia is contraindicated in patients with:  \n• a residual stromal bed thickness that is less than 250 microns from the corneal endothelium;  \n• abnormal corneal topographic findings, e.g., keratoconus, pellucid marginal degeneration;  \n• ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect);  \n• irregular or unstable (distorted/not clear) corneal mires on central keratometry images;  \n• severe dry eye;  \n• active eye infection or inflammation;  \n• recent herpes eye infection or problems resulting from past infection;  \n• active autoimmune disease or connective tissue disease;  \n• uncontrolled diabetes;  \n• uncontrolled glaucoma.  \nIV. WARNINGS AND PRECAUTIONS  \nThe warnings and precautions can be found in the VisuMax® Femtosecond Laser labeling.  \nV. DEVICE DESCRIPTION  \nThe VisuMax® Femtosecond Laser (Figure 1) is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The action of the VisuMax and other femtosecond lasers mimics the cutting action of mechanical or blade-based keratomes. The VisuMax accomplishes this by scanning tightly focused patterns of femtosecond laser pulsesin the cornea at precise and predefined positions and depths. Each laser pulse produces a micro-photodisruption in tissue of only a few microns in size. Patterns of contiguous, focused laser pulses results in the creation of continuous cut surfaces in the cornea.  \nFigure 1. VisuMax® Femtosecond Laser  \nTable 1. The VisuMax® Femtosecond Laser System consists of the following major  \ncomponents:  \n\n| Laser Console | The Laser Console houses the femtosecond laser source, the scanning delivery system, the computer and software-hardware control system, an uninterruptible electrical power supply, the power supply distribution electronics, a visualization system and surgical microscope, two slit illumination units, the interface hardware for the Treatment Pack, user controls and user interface. |\n| --- | --- |\n| Patient Supporting | The Patient Supporting System (PSS) is used to support the patient in a supine position during corneal surgery with the VisuMax® Femtosecond Laser. The PSS |\n\n\n| System | is also used to properly position the patient with respect to the Treatment Pack affixed to the treatment objective lens in the Laser Console. The joystick control on the PSS is manipulated by the user to position the patient with respect to the Treatment Pack, and to applanate and immobilize the eye of the patient in preparation for laser treatment. |\n| --- | --- |\n| AccessoriesTreatment Pack | The VisuMax Treatment Pack is a pre-sterilized, single-use disposable accessory to the VisuMax® Femtosecond Laser. It consists of disposable elements that allow for the laser beam to be properly coupled onto a patient’s cornea in a precise and controlled manner. No cleaning, disinfection or re-sterilization by the user is required or permitted. The Treatment Pack is contained in the blister pack that has been tested to mai","cbCaiffg8XRu0i6l","https://ap.wps.com/l/cbCaiffg8XRu0i6l","pdf",515886,"English","# GENERAL INFORMATION\n## INDICATIONS FOR USE\n## CONTRAINDICATIONS\n## WARNINGS AND PRECAUTIONS\n## DEVICE DESCRIPTION\n## ALTERNATIVE PRACTICES AND PROCEDURES\n## MARKETING HISTORY","[{\"question\":\"What is the VisuMax® Femtosecond Laser used for in the SMILE procedure?\",\"answer\":\"It is used in small incision lenticule extraction (SMILE) to reduce or eliminate myopia within the stated range, subject to the specified ocular measurement criteria and stability of manifest refraction over the past year.\"},{\"question\":\"Which patients are contraindicated for VisuMax SMILE?\",\"answer\":\"Contraindications include too-thin residual stromal bed thickness, abnormal corneal topographic findings such as keratoconus, signs of progressive or unstable myopia, irregular corneal mires, severe dry eye, active eye infection or inflammation, recent herpes eye infection, autoimmune/connective tissue disease, uncontrolled diabetes, and uncontrolled glaucoma.\"},{\"question\":\"Where can the warnings and precautions be found?\",\"answer\":\"The warnings and precautions are provided in the VisuMax® Femtosecond Laser labeling.\"}]","VisuMax® Femtosecond Laser System - SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) | PDF",1789142349]