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 technical and clinical comparison of SculpSure (1060nm contact) and EON (1064nm touchless robotic) laser lipolysis: FDA PKT clearances, delivery mechanisms, and MAUDE…
An evidence-based comparative review of Cellfina and Avéli cellulite subcision devices, analyzing FDA clearances, mechanical subcision pathways, clinical trials, and…
A comprehensive regulatory dossier analyzing AbbVie/Allergan Aesthetics' approvals, BIOCELL textured breast implant recalls, and CoolSculpting and Juvéderm adverse…
An evidence-based pre-treatment guide on blood thinners and supplements for Botox and fillers, analyzing bruising mechanisms, prescription protocols, and technique…
A comprehensive regulatory and safety dossier analyzing Candela's aesthetic laser platforms, FDA 510(k) clearance history, historical recalls, and MAUDE database…
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…