When did the PinPointe™ FootLaser® receive the new FDA clearance?

The PinPointe™ FootLaser® received written FDA clearance effective October 15, 2010.

What was the clearance for?

The PinPointe™ FootLaser® is cleared for the temporary increase of clear nail in patients with onychomycosis.

How does the PinPointe™ FootLaser® work?

The PinPointe™ FootLaser® targets the 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.

What can your patients expect?

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.

Can the patient expect more than one procedure?

Results will vary. You will need to determine if the patient needs follow-up care.

What can I expect in the provider’s office?

The process begins with a consultation in which your provider, will explain the procedure that is to be performed and any follow-up visits that may be required.

Is the procedure painful?

For most patients it is a virtually painless experience. Some may feel a warming sensation. An isolated few may feel a slight pinprick.

Is there a recovery period?

No. The procedure is a walk in/walk out procedure.

How long does the procedure take?

The PinPointe™ FootLaser® procedure typically takes about 30 minutes.

Will the fungus grow back?

Most patients report seeing an improvement after one procedure. 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.

When is it safe for patients to paint their nails or have a pedicure post-procedure?

Patients can apply polish immediately after the procedure. It is important to inform the patient that they should remove all nail polish and nail decorations the day before their procedure.

What do providers typically charge for this procedure?

Typically, about $1,000 per procedure.

What kind of payments can I accept for this procedure?

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.

Can the procedure be covered by their insurance?

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.

How long has the PinPointe™ FootLaser® been in use?

Clinical studies began in November 2007.

Is the PinPointe™ FootLaser® FDA cleared?

Yes, the device has received FDA clearance for the temporary increase of clear nail in patients with Onychomycosis, or nail fungus.

Who developed the PinPointe™ FootLaser® procedure?

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®.

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