Using OMM IMPORTS as a keyword to search the medical device database on the US FDA website, we found four 510(k) substantive equivalent filings, and two of them were actually applied by Chinese agents. The clever fake foreign devils are not looking for Chinese agents now.
Knowledge points: FDA's 510(k) filing is because it is substantially equivalent to a previously marketed medical device, not an endorsement or certification of efficacy.
510(k), also known as PremarketNotification (PMN), corresponds to section 510 k of the Federal Food, Drug, and Cosmetic Act (FD&CAct). 510(k) is a type of premarket application that means that a medical device that is on the market for the first time or a medical device that has been marketed but has significantly changed should be substantially equivalent in safety and efficacy to the FDA by the company before it is officially marketed.
Substantial Equivalent (SE) meanings include:
1. The device has the same intended use and the same technical characteristics after comparison with the reference device that has been legally marketed.
2. The device has the same intended use after comparison with the reference device that has been legally marketed, although it does not have the same technical characteristics, but it does not cause new problems in safety and effectiveness, and can be proved to be as safe and effective as the reference device that has been marketed.
Substantial equivalence is determined on the basis of the intended use, design, energy use or delivery, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labelling, biocompatibility, standards and other characteristics, and does not imply that the device to be marketed must be fully consistent with the reference device already on the market.
In the spirit of tracing back to the roots, I used translation software to read through the four FDA510(k) filings with zero gravity. What happened? This pure plagiarism, the so-called high-tech is the old technical solution of others more than ten years ago. (The old technical solution is also the substantive equivalent of fooling people)
The red and infrared light wavelengths of the first-generation zero-gravity Perfectio LED beauty instrument filed on February 25, 2016 and the Silk'n FX beauty instrument filed on August 19, 2011 are both 633+ 5nm and 830+ 5nm. Total plagiarism, no innovation!
https://silkn.com/products/silkn-facefx-360-anti-aging-device
ps. Fda-recorded efficacy is only for the treatment of wrinkles around the eyes.
Copying the wavelength scheme of the ancient model Of the Israeli brand Silk'n FX, it is the relationship between zero gravity and Israel!
@Wang Hongquan Xingxing is ready to compensate 60 million+ to the deceived consumers.