FDA clearances and approvals, off-label use, scope-of-practice rules, and how to read a 510(k) summary without trusting the marketing wrapper.
A detailed regulatory and compliance dossier analyzing Cutera's aesthetic device portfolio, including Excel V, xeo, and AviClear, alongside historical FDA warnings and…
A comprehensive regulatory dossier analyzing Cynosure's aesthetic laser and RF portfolio, 510(k) clearances, handpiece recalls, and MAUDE adverse events.
A comprehensive regulatory dossier mapping InMode's RF technology architecture (Morpheus8, BodyTite, FaceTite), FDA 510(k) clearances, and post-market safety…
A comprehensive regulatory dossier analyzing Merz Aesthetics' portfolio, Xeomin's BLA registration, Radiesse's and Belotero's PMA history, and Ultherapy PRIME's FDA…
An evidence-based clinical review of NAD+ IV therapy, analyzing the 2025 FDA Class I recall of GenoGenix lots, endotoxin contamination risks, and human clinical trial…
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…
Semaglutide's key US patent runs to late 2031 and tirzepatide's to early 2036. We read the FDA Orange Book to show when generic GLP-1 weight-loss drugs can actually…
The FDA's proposed exclusion of semaglutide and tirzepatide from the 503B Bulks List will end industrial GLP-1 compounding in 2026. A guide to legal timelines and…
Cosmetic Botox is excluded from HSA/FSA funds, but therapeutic Botox for migraine, hyperhidrosis, or TMJ qualifies with an LMN and proper coding. A detailed regulatory…
Plasma pens bypass FDA cosmetic reviews, but voluntary MAUDE databases reveal severe risks of atrophic scarring and hypopigmentation requiring costly laser corrections.