Indigo Medical's laser cleared for general surgery:
This article was originally published in Clinica
Executive Summary
Indigo Medical's portable 830 diode laser system has been cleared by the US FDA for use in general surgery and urological and gastroenterological procedures. Six-month follow-up of 100 patients treated with the laser for benign prostatic hyperplasia is under way in preparation for 510(k) clearance. The system, which is CE-marked, is already marketed for BPH treatment outside the US through Indigo's German and Hong Kong subsidiaries (see Clinica No 672, p 18).