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Tough Questions About Foot Fungus Laser Treatment

CBS Atlanta Questions Local Podiatrist About PinPointe Laser Treatment

POSTED: 6:29 pm EST November 3, 2009
UPDATED: 6:40 am EST November 4, 2009

The Ankle and Foot Centers of Georgia has been promoting a foot fungus laser treatment on its Web site.

Mary Long with the FDA said, "The PinPointe Laser has been cleared for marketing by the FDA for soft tissue cutting. It has not been cleared or approved by the FDA for the treatment of toenail fungus."

However, the Ankle and Foot Centers of Georgia is advertising the foot fungus laser treatment online and it even claims it's 88 percent effective. CBS Atlanta questioned the Piedmont Podiatry about the promotion at their Atlanta practice and they shut the door on us.

The FDA said that doctors can use the laser for any type of treatment, but they are not able to advertise treatments that are not FDA approved.

"Promotion of medical devices for unapproved or uncleared uses violates FDA regulation," said Long.

The Ankle and Foot Centers of Georgia told CBS Atlanta Tuesday that the FDA guidelines for promotion of the PinPointe Laser only apply to the manufacturer.

The FDA responded with this statement, "No, it does not only apply to manufacturers. Section 906 of the Food, Drug and Cosmetic Act refers to our authority over promotion of unapproved uses of legally marketed devices by practitioners."

If the FDA decides to take action, the Ankle and Foot Centers of Georgia could lose its laser.

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