Hydrafacial
Neither HydraFacial nor any generic machine is FDA-cleared, because the category is exempt from FDA review. They are registered as Class I devices under product code GFE, "powered dermabrasion brush," regulation 21 CFR 878.4820, which is 510(k) exempt. There is no K-number to quote, and no cleared use for acne, pores, fine lines or anything else, because nothing was submitted and nothing was reviewed.
Exempt is not the same as unregulated. The maker still has to register with the FDA, list the product, follow manufacturing quality rules, and must not label it falsely. It only means the FDA has never judged whether these machines do what they are sold to do. A two-thousand-dollar imported machine and a thirty-thousand-dollar HydraFacial Syndeo stand in exactly the same place.
HydraFacial is made by Edge Systems, which calls the swirling flow through its spiral tip Vortex-Fusion. Edge Systems holds only three FDA clearances in total, and none is the HydraFacial; they cover sterile tubing and the blue and red LED light modules. A manufacturer statement about a related product line says the serums are meant to meet the FDA definition of a cosmetic, not to treat any disease.
"FDA registered" and "FDA listed" are not quality signals. Every machine in this category has to be registered and listed, whatever it costs. Neither phrase means anything was reviewed.