{"product_id":"fda-510k-k150907-ellipse-nordlys-ellipse-nordlys-ellipse-sirius-ellipse-infinity-ellipse-mjolner-ellipse-nordlys-ultra","title":"FDA 510(k) K150907, Ellipse Nordlys\/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra, by Ellipse A\/S","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eEllipse Nordlys\/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra\u003c\/strong\u003e (K150907), submitted by Ellipse A\/S.\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K150907\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e Powered Laser Surgical Instrument\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Ellipse A\/S\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 04\/03\/2015\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 07\/07\/2015\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Number:\u003c\/strong\u003e 878.481\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e GEX\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubsequent Product Code:\u003c\/strong\u003e ONF\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Medical Specialty:\u003c\/strong\u003e General \u0026amp; Plastic Surgery\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview Panel:\u003c\/strong\u003e General \u0026amp; Plastic Surgery\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal Pages:\u003c\/strong\u003e 1634 (1507 unredacted, 7% redacted overall)\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eWhat's in this document\u003c\/strong\u003e (sections may appear in any order):\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e~ \u003cstrong\u003e510(k) Summary \/ Statement:\u003c\/strong\u003e 40% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eIndications for Use:\u003c\/strong\u003e 80% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eDevice Description:\u003c\/strong\u003e 75% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e 44% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e 78% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e 66% redacted\u003c\/li\u003e\n\u003cli\u003e✓ \u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e 15% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e 92% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e 61% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eClinical Data:\u003c\/strong\u003e 83% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e 33% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e 82% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e 65% redacted\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cem\u003eSection contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.\u003c\/em\u003e\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51454813896868,"sku":"FDA510K150907","price":299.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k150907-ellipse-nordlys-ellipse-nordlys-ellipse-sirius-ellipse-infinity-ellipse-mjolner-ellipse-nordlys-ultra","provider":"FOIA Document Source","version":"1.0","type":"link"}