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2015 ASLMS FDA Update


Iris Rubin, MD, ASLMS Director of Government Communication and Education

The ASLMS has been collaborating with the FDA for the last seven years to provide educational meetings at the FDA. The goal of the meetings is to provide an unbiased educational forum and two-way exchange of information about lasers and related technology and the challenges of bringing technology forward. The last two years a teleconference format was implemented.

Recent teleconference sessions were held on November 2, 2015, and November 16, 2015. The program directors were Dr. Iris Rubin, representing the ASLMS and Dr. Mat Avram representing the ASDS, and Mr. Neil Ogden and Mr. Richard Felten from the Center for Devices and Radiological Health (CDRH) Office of Device Evaluation at the FDA.

Presentations were as follows:

November 2, 2015

  • Low level light, mechanism of action. Juanita Anders, PhD
  • Low level light, clinical applications. Raymond Lanzafame, MD, MBA
  • Safety of prolonged treatment with over the counter aesthetic devices. Robert Weiss, MD, Jeffrey Dover, MD, David McDaniel, MD

November 16, 2015

  • How are dermal fillers used in practice vs. how they are labeled/approved. H. Ray Jalian, MD
  • How are dermal fillers injected (needle vs. cannula)? Adverse effects, including reports of blindness. Mathew Avram, MD, JD
  • Combination treatments with filler and laser/energy/light source. Is it better to do filler or laser/energy/light source treatment first? Suzanne Kilmer, MD

Topics were selected by discussing with the FDA what would be helpful and of interest to the FDA. There were 33 attendees from the FDA for the November 2 meeting, and 45 for the November 16 meeting. FDA attendance was both in person and remote. The presentations were well received, and we received feedback from the FDA that they received the information they were looking for. As in previous years there was an active question and answer period. Plans are in place for a teleconference meeting to be held in 2016 on laser treatment of traumatic scars.

In addition, the ASLMS is formally a part of the FDA's Network of Experts for the Center for Devices and Radiological Health (CDRH). This program allows the FDA to consult ASLMS faculty for their scientific and medical expertise on an as needed basis.

The American Society for Laser Medicine and Surgery is the world’s largest scientific organization dedicated to promoting research, education and high standards of clinical care in the field of medical laser applications. It provides a forum for the exchange of scientific information and participation in communicating the latest developments in laser medicine and surgery to clinicians, research investigators, government and regulatory agencies, and the public.

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