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Medical Spa MD is a world-wide physician community for clinicians in skin clinics, laser centers and medspas with thousands of physician members around the world. By using this site you agree to our terms of service and fine print.

Medspa Legal & Legislation > Cellulite reduction

I'm an unlicensed medical doctor in Texas, I have received training for acoustic wave therapy, this is a class 1 medical device none invasive by FDA my questions are:
1-who can give acoustic wave therapy for cellulite reduction?
2-what kind of licenses are required to operate the device
3- do i need a medical director?
4-what kind of license or permit i need for the location?

Thanks a lot

Unlicensed medical doctor?

Yes, acoustic wave therapy, is not consider as a medical procedure! now would you pls take a look to my questions? thanks

Dear Robert: "Acoustic wave therapy" is not a recognized modality by the CDRH or the FDA. If you are talking about a form of ultrasound energy it is probably going to fall into one of the regulated FDA categories such as "ultrasound diathermy" or a similar category. The state of Texas also regulates the use of "medical devices". This is complex. You need to consult with a licensed attorney if you want to stay out of trouble.

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