{"product_id":"avologie-scientific-eneo-totale","title":"Avologie Scientific Eneo Totalé - The ultimate skin rejuvenation device!","description":"\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eThe ultimate second-generation skin rejuvenation device!\u003c\/p\u003e\n\u003cp\u003eMade with innovative anti-aging technology developed by a Nobel prize-winning scientist. The ENEO TOTALÉ delivers and reveals smoother, more radiant-looking skin.\u003c\/p\u003e\n\u003cp\u003eENEO TOTALÉ is a dermatology-recommended, clinically tested red and near-infrared LED photobiomodulation device that is FDA 510(k)-cleared under K213841 for over-the-counter wrinkle reduction.\u003c\/p\u003e\n\u003ch4 class=\"elementor-heading-title elementor-size-default\"\u003e\u003cbr\u003e\u003c\/h4\u003e\n\u003ctable align=\"center\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003eDevice Classification Name\u003c\/th\u003e\n\u003ctd align=\"left\"\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpcd\/classification.cfm?start_search=1\u0026amp;productcode=OHS\" title=\"Products Classification Database Information for Light Based Over The Counter Wrinkle Reduction\"\u003eLight Based Over The Counter Wrinkle Reduction\u003c\/a\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e510(k) Number\u003c\/th\u003e\n\u003ctd align=\"left\"\u003eK213841\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr valign=\"top\"\u003e\n\u003cth align=\"left\"\u003eDevice Name\u003c\/th\u003e\n\u003ctd align=\"left\"\u003eENEO TOTALE (Model: ENEOT947)\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr valign=\"top\"\u003e\n\u003cth align=\"left\"\u003eApplicant\u003c\/th\u003e\n\u003ctd align=\"left\"\u003e\n\u003ctable border=\"0\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr valign=\"top\"\u003e\n\u003ctd align=\"left\"\u003ePremier North America, Inc.\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e3301 SW 42nd St.\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003eFort Lauderdale,  FL  33312\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003eApplicant Contact\u003c\/th\u003e\n\u003ctd align=\"left\"\u003eEllis Tamari\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr valign=\"top\"\u003e\n\u003cth align=\"left\"\u003eCorrespondent\u003c\/th\u003e\n\u003ctd align=\"left\"\u003e\n\u003ctable border=\"0\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr valign=\"top\"\u003e\n\u003ctd align=\"left\"\u003eShanghai CV Technology Co., Ltd.\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003eRm. 903, #19 Dongbao Rd., Songjiang Area,\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003eShanghai,  CN 201613\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003eCorrespondent Contact\u003c\/th\u003e\n\u003ctd align=\"left\"\u003eDoris Dong\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003eRegulation Number\u003c\/th\u003e\n\u003ctd align=\"left\"\u003e\u003ca href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-878.4810\" title=\"Code of Federal Regulations (CFR) database information for 878.4810\" alt=\"Code of Federal Regulations (CFR) database information for 878.4810\"\u003e878.4810\u003c\/a\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr valign=\"top\"\u003e\n\u003cth align=\"left\"\u003eClassification Product Code\u003c\/th\u003e\n\u003ctd align=\"left\"\u003e\n\u003ctable border=\"0\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003ca href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpcd\/classification.cfm?start_search=1\u0026amp;productcode=OHS\"\u003eOHS\u003c\/a\u003e  \u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003eDate Received\u003c\/th\u003e\n\u003ctd align=\"left\"\u003e12\/09\/2021\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003eDecision Date\u003c\/th\u003e\n\u003ctd align=\"left\"\u003e01\/06\/2022\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003eDecision\u003c\/th\u003e\n\u003ctd align=\"left\"\u003eSubstantially Equivalent (SESE)\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003eRegulation Medical Specialty\u003c\/th\u003e\n\u003ctd align=\"left\"\u003eGeneral \u0026amp; Plastic Surgery\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e510k Review Panel\u003c\/th\u003e\n\u003ctd align=\"left\"\u003eGeneral \u0026amp; Plastic Surgery\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003eSummary\u003c\/th\u003e\n\u003ctd align=\"left\"\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf21\/K213841.pdf\" title=\"PDF for K213841\"\u003eSummary\u003c\/a\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003eType\u003c\/th\u003e\n\u003ctd align=\"left\"\u003eSpecial\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003eReviewed by Third Party\u003c\/th\u003e\n\u003ctd align=\"left\"\u003eNo\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003eCombination Product\u003c\/th\u003e\n\u003ctd align=\"left\"\u003eNo\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003ePredetermined Change\u003cbr\u003eControl Plan Authorized\u003c\/th\u003e\n\u003ctd align=\"left\"\u003eNo\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e","brand":"Rathfarnham Pharmacy","offers":[{"title":"Default Title","offer_id":57163409621318,"sku":null,"price":3995.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0957\/6631\/5334\/files\/images_9.jpg?v=1787581148","url":"https:\/\/thepharmacyshop.ie\/products\/avologie-scientific-eneo-totale","provider":"Rathfarnham Pharmacy","version":"1.0","type":"link"}