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 regulatory and clinical profile analyzing Prollenium's Revanesse filler line, its single FDA PMA P160042 architecture, Thixofix cross-linking, and MAUDE safety data.
A regulatory and clinical profile analyzing Teoxane's RHA Collection, its single FDA PMA P170002 architecture, Preserved Network Technology, and post-market safety data.
A regulatory and safety profile of Alma Lasers' portfolio, analyzing its 26 FDA clearances, Soprano and Harmony lineages, Sisram Medical ownership, and openFDA MAUDE…
A regulatory and safety profile of Fotona's portfolio, analyzing its 38 FDA clearances, SP Dynamis dual-wavelength platform, NightLase snoring protocol, and MAUDE record.
A regulatory and safety profile of Lutronic's portfolio, analyzing its 24 FDA clearances, Cynosure Lutronic merger, Clarity II recall, and openFDA MAUDE record.
A comprehensive clinical and regulatory guide to interstitial laser-assisted lipolysis (SmartLipo) and laser cellulite subcision (Cellulaze), comparing them with VASER…
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.
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…