510(k) for Premier Laser Systems:
This article was originally published in Clinica
Executive Summary
The FDA has cleared Premier Laser Systems' Aurora diode laser for removing dental coronal pulp in pulpotomy and root canal procedures. An additional handpiece has also been designed to carry out the newly-cleared procedures and can be used to upgrade previously installed diode lasers. For the past two years, the device has been used by dental surgeons various soft tissue procedures including incision, excision, vaporisation, ablation, and haemostasis, without sutures or post-operative complications. The Irvine, California-based company says patients treated with the Aurora diode laser which experience minimal or no pain and recover more quickly.