FDA clearances and approvals, off-label use, scope-of-practice rules, and how to read a 510(k) summary without trusting the marketing wrapper.
An evidence-based guide to 808/810 nm diode laser hair removal. Covers Fitzpatrick skin-type safety, FDA 510(k) clearances, and MAUDE database safety profile.
An evidence-based guide to hyperdiluted Radiesse (calcium hydroxylapatite) for skin tightening and body biostimulation, detailing dilution protocols, FDA PMA status, and…
Profiles Lumenis's aesthetic laser portfolio, its FDA 510(k) clearance history, post-market safety record in openFDA MAUDE, and corporate ownership.
A clinical comparison of Type A (Botox) and Type B (Myobloc) neuromodulators, detailing their distinct molecular targets, duration, pH levels, and FAERS safety data.
A clinical and regulatory review of the DeScribe PFD Patch for laser tattoo removal. Learn how perfluorodecalin clears epidermal frosting to enable multi-pass protocols.
A head-to-head comparison of the leading FDA-cleared mechanical powered microneedling pens. Examines FDA product code QAI clearances, technical specifications, and…
A review of the newest FDA dermal filler approvals (Evolysse, saypha MagIQ, Belotero Volume) under product code LMH. Compares chemistry, cross-linking technology, PMA…
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…