Unable to Find FDA-Approved Lasers for Nail Fungus Removal (infections, skin, doctor)

[Priya36]

Nail fungus is aggressive so treatment must be aggressive.


Looking for FDA-Approved Lasers for Nail Fungus Removal.


So far I seem to turn up dead-ends. Below is what I did, please advise on other routes.


Article talks about laser treatment for Nail Fungus Removal
https://www.verywellhealth.com/laser...fungus-1337803

"Several types of laser devices have been cleared by the FDA for the treatment of onychomycosis, including PinPointe Footlaser, GenesisPlus, and Noveon. According to the criteria for approval, these devices may produce a "temporary increase in clear nails in patients with onychomycosis."


I search PinPointe Footlaser and it has website. Plus the patient can search for nearby provider
https://toenailfunguslaser.com/patie...nd-a-provider/


I search GenesisPlus and cannot find their website. Only Podiatrists who say they use the laser.


I search Noveon and cannot find their website.


I do find 2009 NY Times article that talks about Noveon, https://www.nytimes.com/2009/03/20/b.../20fungus.html

"After four treatments with Noveon, about half of the 39 toenails tested no longer had active nail infections, according to the results of a clinical trial that the company presented this month at a national dermatology meeting. Six months after the initial treatment, about 76 percent of the volunteers had clear nail growth, the study reported."


I understand Lasers and Companies come and go. So I went to FDA.gov to search for information.

I searched "nail fungus laser" and found irrelevant articles
I search PinPointe Footlaser and it returned "Sorry, no results"
I search GenesisPlus and got articles on genes
I search Noveon and I am getting excel files


I emailed the FDA and am yet to hear back.


How do I search for and verify that lasers are FDA approved for nail fungus removal. From there I can contact the manufacturer and who does treatment near Patient's location.

[Deserterer]

Originally Posted by Priya36

Nail fungus is aggressive so treatment must be aggressive.


Looking for FDA-Approved Lasers for Nail Fungus Removal.


So far I seem to turn up dead-ends. Below is what I did, please advise on other routes.


Article talks about laser treatment for Nail Fungus Removal
https://www.verywellhealth.com/laser...fungus-1337803

"Several types of laser devices have been cleared by the FDA for the treatment of onychomycosis, including PinPointe Footlaser, GenesisPlus, and Noveon. According to the criteria for approval, these devices may produce a "temporary increase in clear nails in patients with onychomycosis."


I search PinPointe Footlaser and it has website. Plus the patient can search for nearby provider
https://toenailfunguslaser.com/patie...nd-a-provider/


I search GenesisPlus and cannot find their website. Only Podiatrists who say they use the laser.


I search Noveon and cannot find their website.


I do find 2009 NY Times article that talks about Noveon, https://www.nytimes.com/2009/03/20/b.../20fungus.html

"After four treatments with Noveon, about half of the 39 toenails tested no longer had active nail infections, according to the results of a clinical trial that the company presented this month at a national dermatology meeting. Six months after the initial treatment, about 76 percent of the volunteers had clear nail growth, the study reported."


I understand Lasers and Companies come and go. So I went to FDA.gov to search for information.

I searched "nail fungus laser" and found irrelevant articles
I search PinPointe Footlaser and it returned "Sorry, no results"
I search GenesisPlus and got articles on genes
I search Noveon and I am getting excel files


I emailed the FDA and am yet to hear back.


How do I search for and verify that lasers are FDA approved for nail fungus removal. From there I can contact the manufacturer and who does treatment near Patient's location.

You are going about it backwards. You'll have better luck just contacting podiatriist in your area, physician referral services or even the patient's insurance company. or how about Googling that treatment for your area-I believe in the past you said you were in NY. Several options come up.



https://www.google.com/search?q=new+...aser+treatment

[mike1003]

Originally Posted by Priya36

Nail fungus is aggressive so treatment must be aggressive.


Looking for FDA-Approved Lasers for Nail Fungus Removal.


So far I seem to turn up dead-ends. Below is what I did, please advise on other routes.


Article talks about laser treatment for Nail Fungus Removal
https://www.verywellhealth.com/laser...fungus-1337803

"Several types of laser devices have been cleared by the FDA for the treatment of onychomycosis, including PinPointe Footlaser, GenesisPlus, and Noveon. According to the criteria for approval, these devices may produce a "temporary increase in clear nails in patients with onychomycosis."


I search PinPointe Footlaser and it has website. Plus the patient can search for nearby provider
https://toenailfunguslaser.com/patie...nd-a-provider/


I search GenesisPlus and cannot find their website. Only Podiatrists who say they use the laser.


I search Noveon and cannot find their website.


I do find 2009 NY Times article that talks about Noveon, https://www.nytimes.com/2009/03/20/b.../20fungus.html

"After four treatments with Noveon, about half of the 39 toenails tested no longer had active nail infections, according to the results of a clinical trial that the company presented this month at a national dermatology meeting. Six months after the initial treatment, about 76 percent of the volunteers had clear nail growth, the study reported."


I understand Lasers and Companies come and go. So I went to FDA.gov to search for information.

I searched "nail fungus laser" and found irrelevant articles
I search PinPointe Footlaser and it returned "Sorry, no results"
I search GenesisPlus and got articles on genes
I search Noveon and I am getting excel files


I emailed the FDA and am yet to hear back.


How do I search for and verify that lasers are FDA approved for nail fungus removal. From there I can contact the manufacturer and who does treatment near Patient's location.

If you want one for home use, you will never find one, too dangerous


Find a good Podiatrist


I did a simple search for PinPoint and got many responses


https://duckduckgo.com/?t=ffcm&q=Pin...=v199-1&ia=web

[terracore]

I've always cured it with a diluted chlorox bleach solution. I follow the disinfecting dilution ratio on the bottle. Soak affected area 5 minutes a day until the nail starts growing in healthy. It works even if occasionally miss a day. For me it lasts about 10 years and then the fungus returns and I repeat the treatment. Works fast and costs pennies. Cures athlete's foot too. If skin gets irritated, dilute with more water. Don't use any other brand other than chlorox.

[Priya36]

Originally Posted by Deserterer

You are going about it backwards. You'll have better luck just contacting podiatriist in your area, physician referral services or even the patient's insurance company. or how about Googling that treatment for your area-I believe in the past you said you were in NY. Several options come up.



https://www.google.com/search?q=new+...aser+treatment

Podiatrist (or any other Medical professional) wants to make money whether Patient gets better or not. My experiences.

Hence, I wanted to go this route.

Thank you.

[reed303]

From what Mike 1003 found, and this FDA info,

https://www.accessdata.fda.gov/scrip...on.cfm?id=6043

it appears these lasers are only approved for improving the appearance of the nail, not for curing the fungus itself. You still need drugs or creams (or some home remedies) to stop the fungus itself.

[Priya36]

Originally Posted by reed303

From what Mike 1003 found, and this FDA info,

https://www.accessdata.fda.gov/scrip...on.cfm?id=6043

it appears these lasers are only approved for improving the appearance of the nail, not for curing the fungus itself. You still need drugs or creams (or some home remedies) to stop the fungus itself.

This is extremely helpful.

No wonder insurance won't pay for it. Lasers are proven to be cosmetic, not medical treatment.

[Lillie767]

Originally Posted by Priya36

Podiatrist (or any other Medical professional) wants to make money whether Patient gets better or not. My experiences.

Hence, I wanted to go this route.

Thank you.

So, are you going to call a doctor to treat this medical condition?