{"product_id":"fda-510k-k192539-deka-luxea","title":"FDA 510(k) K192539, Deka Luxea, by El.En Electronic Engineering Spa","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eDeka Luxea\u003c\/strong\u003e (K192539), submitted by El.En Electronic Engineering Spa.\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K192539\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 El.En Electronic Engineering Spa\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 09\/16\/2019\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 12\/16\/2019\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 3712 (3193 unredacted, 13% 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 25% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eIndications for Use:\u003c\/strong\u003e 23% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eDevice Description:\u003c\/strong\u003e 42% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e 26% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e 48% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e 60% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e 100% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e 71% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e 38% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eClinical Data:\u003c\/strong\u003e 54% redacted\u003c\/li\u003e\n\u003cli\u003e✓ \u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e 15% redacted\u003c\/li\u003e\n\u003cli\u003e✓ \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e 0% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e 38% 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":51454814060708,"sku":"FDA510K192539","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-k192539-deka-luxea","provider":"FOIA Document Source","version":"1.0","type":"link"}