Let me ask a few questions to those of you who understand the legal aspects of the laser/medical spa world. First, how can people (non medical/non licensed) purchase prescriptive medical devices. I have checked with the FDA and there are only two ways a person can purchase a prescriptive medical device: (1) they have prescriptive authority in that state or (2) the clinic that is purchasing said devices is a licensed medical clinic and owned and run by doctors. So how can a Laser Franchise sell its franchise to someone who cannot legally purchase the device needed to run said franchise, as stated by the FDA:

Medical Devices. Purchasers of medical device items hereby certify and assure that such items will be used or resold only under the conditions specified below:

Medical device items are subject to the laws and regulations administered by the Food and Drug Administration (FDA). Provisions of the governing statute, the Federal Food, Drug and Cosmetic Act appear in 21 U.S.C. 331, et. seq . In summary, the Act prohibits the movement in interstate commerce of medical devices that are misbranded or adulterated. The Act authorizes FDA to initiate criminal enforcement proceedings against companies and/or individuals responsible for violations of its provisions. Moreover, the Act authorizes FDA to initiate civil proceedings to seize, or enjoin the distribution of such items. Prescription devices are subject to additional Federal, state and other applicable laws. Federal law requires that prescription devices be in the possession of either persons lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device, or practitioners licensed by their state. Federal law also requires that prescription devices be sold only to or on the prescription or order of a licensed practitioner for use in the course of his or her professional practice, and that the devices are labeled in a specific manner. Refer to 21 CFR 801.109.

So, if a laser franchise, with the help of a laser manufacturer are deceptively working together to sell Laser Franchise and equiptment to people who do not meet FDA criteria...wouldn't FTC Franchise Law of "Full Disclosure" be violated? Profit over People...surprising...NOT!

As far as I know these franchise states in their UFOC that they are not " in the practice of medicine." So if they are not in the practice of medicine, and the laser companies know this how do they get around selling devices to people who don't have authority and since they are not in the "practice of medicine" they could not be licensed by the state.

Please don't say a "Medical Director." There is no state that would allow a doctor to "grant" prescriptive authority to a person who dosent have a medical degree. Hell it took nurses decades to get perscriptive authority and they have a freaking degree. The sad truth is most of these "Medical Directors" don't even know what or how a laser works. They were never trained and have zero clue what they are authorizing. Sad but true.

Some of the equiptment being pitched by these franchise have a Rx sticker on the device...here's what the FDA says about that: Prescriptive Device: 809.109 "Its labeling bears an Rx statement, i.e. "Caution: Federal law restricts this device to sale by or on the order of a (insert name of physician, dentist, or other licensed practitoner);

So if someone can help me understand how this works I would greatly appreciate it. It seems like a good old scam, deceptive marketing and fraud to be more blunt!

Just for fun:
I went onto Ebay and put "Syneron-laser" into the search engine and pulled up 17 used lasers for sale- looks like the guy who empties your garbage could buy one of he had the $$.
Where's the regulation there?

Dr. No,

Just because your not a physician doesn't mean you can't purchase medical equipment. A Physician Management Group can own the practice and the Doctors, NP's, PA's and RN's would be employees of the Physician Management Group. Alot of Medical Practices are owned by groups such as these and the Doc's don't even have the right to fire the RN's since they don't actually work for the Doc's. A Medical Spa can operate in the same fashion.

As far as a franchise the franchisee or owner or physician management group still owns the practice and it is the responsibility of the owners to make sure they set up the practice legally in each State they operate a clinic.

Dr. Who,
Assuming that a spa is using prescriptive lasers to perform treatments but is not licensed with the state medical board and is not owned by a physician, how are they allowed to purchase such equipment that is for "sale by or on the order of a (insert name of physician, dentist, or other licensed practitoner)"?

Medspa,

You buy the equipmet through the Physician Management Group. How do you think Hospitals such as HCA and Rehab Clinics such as HealthSouth buy equipment.

Clinics and medical practices across the country are owned by PMG's and the Doc's are employees. Not every doctor ownes his own clinic whether it be Internal, Derm whatever. Not all Doc's want the headache of owning the clinic, just because your a doctor doesn't mean you have to be the owner. You still need licensed practitoners seeing patients (Dr. NP, PA, RN or LPN)

Hope this helps.

Does the medspa need to be licensed as a medical facility to purchase the equipment?

It depends on the state where the medspa is located. In most states medspas do not practice medicine. You would need to check with a law firm that deals with healthcare law.