EU MDR, CE Marking, and EUDAMED for Aesthetic Devices Explained
How the European Union Medical Device Regulation regulates aesthetic lasers, fillers, and implants, the 2026 EUDAMED mandatory deadlines, and how a CE mark compares to…
Energy-based devices — fractional CO₂, erbium, picosecond, alexandrite, Nd:YAG, KTP, PDL, IPL. The chromophore framework and what each actually does.
How the European Union Medical Device Regulation regulates aesthetic lasers, fillers, and implants, the 2026 EUDAMED mandatory deadlines, and how a CE mark compares to…
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.
Profiles Lumenis's aesthetic laser portfolio, its FDA 510(k) clearance history, post-market safety record in openFDA MAUDE, and corporate ownership.
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.