Ultherapy, Sofwave, Thermage FLX, Plasma fibroblast. Ultrasound vs RF vs hybrid — and the limits of non-surgical lift.
Profiles Sciton's aesthetic device portfolio, its 21 FDA 510(k) clearances, BBL gene-expression evidence, and openFDA MAUDE safety record.
Profiles Solta Medical's aesthetic device footprint, its 32 FDA 510(k) clearances, openFDA MAUDE post-market safety records, and corporate ownership under Bausch Health.
A comprehensive regulatory dossier mapping InMode's RF technology architecture (Morpheus8, BodyTite, FaceTite), FDA 510(k) clearances, and post-market safety…
Emface pairs synchronized radiofrequency with HIFES facial-muscle stimulation. We break down what the FDA cleared it for, what the small manufacturer studies show, and…
Plasma pens bypass FDA cosmetic reviews, but voluntary MAUDE databases reveal severe risks of atrophic scarring and hypopigmentation requiring costly laser corrections.
Only about 10 registered trials back thread lifts, and most are non-randomized. Large case series show a real lift lasting roughly 6 to 12 months — not the years…
66 FDA MAUDE reports for microneedling devices: Ellacor leads with 28 reports, SkinPen injuries rising in 2025, and FDA's Oct 2025 RF microneedling safety warning.
223 FDA MAUDE reports for ultrasound aesthetic devices: Ultherapy drives 72% of events, Sofwave surged in 2025, and 91% describe patient injuries including burns and fat…
Laser, IPL, RF microneedling, and ultrasound devices all reach the US market through the FDA 510(k) pathway. Here is how that process works, what cleared means, and what…
Ultherapy PRIME received FDA clearance for skin laxity on the abdomen and arms. What changed, how real-time visualization works, what the evidence shows, and what to ask.