Lumina https://luminanrg.Com/products/fat-iron-gel-primer is selling a conductive gel (regulated by 21 cfr 882.1275).It has no list of ingredients on it.It has no warnings or caution statements as required of other electroconductive gels.Their gel has never had an fda-compliant label.I asked where it is, and was told "the gel is fda approved." this means they must have submitted 510(k) premarket disclosures for the gel, right? if yes, where is the label? it's not on the bottle.It's not on the website.I did not buy their gel.However, the gel originally distributed with their electroconductive medical device (which i purchased via their kickstart campaign a few years ago) also lacks a label.I still have that original package.
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