Press Release: FDA 510(k) clearance for onychomycosis (toenail fungus)

Aspen Laser Systems announces new FDA 510(k) clearance for onychomycosis (toenail fungus).

Aspen Laser Systems, the emerging leader in laser technology for Medical, Podiatry and Veterinary, has received FDA 510(k) clearance for the Pinnacle Series Laser System for onychomycosis, also known as toenail fungus.  This FDA clearance sets Aspen Laser Systems aside as a progressive laser company with multiple FDA clearances – allowing more approved uses and versatility for its physician customers.

“At the end of the day, patients need to see results from their doctors,” stated Charles Vorwaller, Chief Executive Officer of Aspen Laser Systems, LLC.  He continues, “allowing our customers to market treatments for onychomycosis empowers them to build their practice in a compliant, profitable, and effective way – all while keeping patient care the #1 priority.”

FDA Cleared Laser Therapy 510k

Many podiatrists have been reluctant to adopt lasers into their practice, considering lasers one-dimensional.  These new systems, however, allow doctors a much wider variety of uses and protocols.  Return on investment comes more quickly from multiple revenue streams and patients recognizing the difference in care, which improves patient referrals and word-of-mouth to the practice.  In addition to 510(k) clearance for onychomycosis, Aspen Laser Systems are effective in the treatment of plantar fasciitis, achilles tendonitis, arthritis, joint pain, warts, wounds, neuroma, neuropathy, and post trauma conditions, as well as surgical applications.

In partnership with one of the most recognized laser manufacturers in the world, Aspen Laser Systems boast variable wattage, preset and customized protocols based on treatments and type of use (therapy, surgical, etc.), along with other advantages.

Dr. Jeff Sands, President of Aspen Laser Systems, LLC, commented, “Gaining multiple clearances proves value and versatility to our physician customers, and more importantly provides enhanced clinical and financial benefits for their practices.  This FDA clearance has us excited for the next innovations we can bring to our physician customers tomorrow.”

Multiple treatment options, experienced clinical training, advanced laser technology, excellent customer service and support including a multi-year warranty are just a few of the advantages that come with the purchase of an Aspen Laser System.

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