FDA Approved PinPointe FootLaser for Nail Fungus Treatment
Ian C. Langtree - Writer/Editor for Disabled World (DW)
Published: 2010/10/26 - Updated: 2025/05/19
Publication Type: Informative
Topic: Finger and Toenails - Publications List
Page Content: Synopsis - Introduction - Main - Insights, Updates
Synopsis: This report announces the U.S. Food and Drug Administration's clearance of the PinPointe FootLaser for treating onychomycosis, a persistent fungal nail infection affecting over 35 million Americans. The PinPointe FootLaser employs a patented laser beam that penetrates the nail to target and reduce fungal infection in the nail bed, offering a relatively painless outpatient procedure without the need for anesthesia. Unlike traditional treatments such as oral antifungal medications - which may have systemic side effects - or surgical nail removal, this laser therapy minimizes discomfort and avoids drug-related complications. The device's FDA clearance is supported by significant clinical research, underscoring its efficacy and safety.
This advancement is particularly beneficial for individuals who are elderly, have disabilities, or possess conditions like diabetes, where conventional treatments pose higher risks. By providing a non-invasive and effective alternative, the PinPointe FootLaser represents a meaningful development in podiatric care - Disabled World (DW).
Introduction
The PinPointe FootLaser has received clearance from the U.S. Food and Drug Administration (FDA) for the treatment of nail fungus (onychomycosis).
Main Content
Toenail fungus, a condition that affects more than 35 million Americans, is both easily spread and exceptionally durable, often standing up against the most aggressive anti-fungal pills. With FDA clearance of the PinPointe FootLaser, patients have a relatively painless, important new treatment option. It is often more successful than topically applied anti-fungal drugs, has less side effects than oral medication, and is less painful than surgical removal of the nail.
Fungal nail infection is caused by fungus under the nail. As they grow, fungi feed on keratin, the tough protein that makes up the hard surface of the nails. The nail becomes darker in color and debris may accumulate under the nail. Nail infection can cause nails to be discolored, thickened, brittle, and 'crumbly' and in some people it can interfere with wearing shoes and/or cause pain when walking.
The treatment of nail infection is difficult because the infection is under and inside of the nail, making it hard for any treatment to reach and destroy the infection. Some people are treated with medicated nail polish or oral medications, which can be associated with side effects and serious drug interactions. Another option is to surgically remove the nail.
The PinPointe FootLaser is a patented laser device that has been showed in clinical studies to significantly reduce nail infection. The patented PinPointe FootLaser is a specially designed laser beam that goes through the nail and safely reduces the infection in the nail bed that cause onychomycosis. It is now FDA cleared and backed by significant clinical research.
The procedure requires one or a small number of safe, quick treatments with little or no discomfort and is performed as an outpatient service with no anesthesia. The gentle laser light beam has no effect on healthy tissue and treats only the infected area. No drugs or topical ointments are used, eliminating the total-body side effects of traditional oral medications.
PinPointe and FootLaser are trademarks of PinPointe USA, Inc.
Insights, Analysis, and Developments
Editorial Note: The FDA's clearance of the PinPointe FootLaser signifies a noteworthy progression in the management of onychomycosis, especially for patients seeking alternatives to systemic medications or invasive procedures. Its non-pharmacological approach aligns with a growing emphasis on patient-centered care, offering a treatment that is both effective and considerate of individual health profiles. As the healthcare community continues to prioritize safe and accessible interventions, technologies like the PinPointe FootLaser exemplify the potential of innovation to enhance quality of life for those affected by chronic conditions - Disabled World (DW).
Author Credentials: Ian is an Australian-born writer, editor, and advocate who currently resides in Montreal, Canada. He is the founder and Editor-in-Chief of Disabled World, a leading resource for news and information on disability issues. With a global perspective shaped by years of travel and lived experience, Ian is a committed proponent of the Social Model of Disability-a transformative framework developed by disabled activists in the 1970s that emphasizes dismantling societal barriers rather than focusing solely on individual impairments. His work reflects a deep commitment to disability rights, accessibility, and social inclusion. To learn more about Ian's background, expertise, and accomplishments, visit his full biography.