Q: When did the PinPointe FootLaser receive the new FDA clearance?
A: PinPointe USA received written FDA clearance effective October 15, 2010
Q: What was the clearance for?
A: The PinPointe FootLaser is cleared for the temporary increase of clear nail in patients with onychomycosis.
Q: How does the PinPointe FootLaser work?
A: The PinPointe FootLaser kills fungus that lives in and under the nail. The laser light passes through the nail without causing damage to the nail or the surrounding skin. At the time of the procedure, the toenail will not become instantly clear— it takes time to grow out.
Q: What can your patients expect?
A: The process begins with a consultation in which you explain the procedure that is to be performed and any follow-up visits that you prescribe.
Q: Can the patient expect more than one treatment?
A: Typically, one treatment kills the fungus for most patients. You will determine if the patient needs follow-up care.
Q: Is the procedure painful?
A: Most patients feel no pain. Some may feel a warming sensation. An isolated few may feel a slight pinprick.
Q: Is there a recovery period?
A: No. The treatment is a walk in/walk out procedure.
Q: How long does the procedure take?
A: The PinPointe FootLaser procedure typically takes about 30 minutes
Q: Will the fungus grow back?
A: The fungus is killed after one treatment. However, there is a chance of reinfection because the fungus is present everywhere in the environment. You can recommend care techniques to help reduce a recurrence of the infection.
Q: When is it safe for patients to paint their nails or have a pedicure posttreatment?
A: Patients can apply polish immediately after the treatment. It is important to inform the patient that they should remove all nail polish and nail decorations the day before their treatment.
Q: What do providers typically charge for this procedure?
A: Typically, about $1,000 per procedure.
Q: What kind of payments can I accept for this procedure?
A: Credit cards, cash, and money orders can be accepted. The patient may also use their Medical IRA, Health Savings Account (HSA), or Flexible Spending Accounts.
Q: Can the procedure be covered by their insurance?
A: If they have a HSA or Medical IRA, 100% of cost can be covered. However, in most situations, this procedure is considered aesthetic, and therefore health insurance plans do not provide coverage.
Q: How long has the PinPointe FootLaser been in use?
A: Clinical studies began in November 2007.
Q: Is the PinPointe FootLaser FDA cleared?
A: Yes, the device has received FDA clearance.
Q: Who developed the PinPointe FootLaser procedure?
A: Leading scientists and medical professionals working together for 20 years with funding provided by the National Institutes of Health developed the technology used in the patented PinPointe FootLaser.