I was wondering if someone could answer these question. A very prominent laser company has provided some documentation stating that they can sell prescription medical devices to business people, because as they stated, "the FDA states they can sell "To or on order of a licensed practioner." What they are saying is if a "licensed practioner" signs a laser leases and acts as your "medical director" then you can buy the lasers.

Is this true? Isn't "To or on order of a licensed practioner" a prescription? Aren't prescriptions a legal document between a physician and a patient? How can the patient, turn around and use the lasers to run a laser clinic? The lasers are not owned by a doctor, they are owned by the patient. The patient isn't a doctor; the clinic isn't a licensed medical facility, as stated by the "laser franchise".

XVI-a. "Prescription device'' or "legend device'' means an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including any component part or accessory, which is restricted for distribution and use only upon the order of a licensed practitioner.

"Prescription" means a lawful order of a practitioner for a drug, a device or diagnostic agent for a specific patient.

A lot of questions...a lot of confusion. Thanks for your help.

Can a laser company sell a prescription medical device to business people?

First, a disclaimer. The issue cannot be fully evaluated with the limited set of facts provided and without knowing the State, the device, and the type of licensed practitioner that is serving as the medical director since not all health care professionals are permitted to perform procedures with lasers. You should consult an attorney before entering into a purchase or lease agreement.

In general, laser and intense pulsed light (IPL) devices used for hair removal and skin treatments are classified by the FDA as laser surgical instruments for use in general and plastic surgery and dermatology. See 21 CFR Section 878.4810. A laser distributor should not sell or lease a device to a person who cannot lawfully use the device. A medical device distributor cannot sell a prescription medical device to a non-physician at that person’s request. Companies that distribute prescription medical devices are not permitted to encourage or to assist a person in providing medical services without a license.

Because prescription medical devices can only be sold or delivered on the order of a health care practitioner, the product distributor is obligated to dispense such products only to persons who are lawfully permitted to acquire such devices under the law of each State. Product distributors cannot lawfully sell a restricted device to any person as though the product had received FDA clearance for over-the-counter distribution. Federal regulations restrict the sale or distribution of prescription medical devices to physicians or any other practitioner licensed by the law of the State in which he or she practices to use or order the use of the device.

A distributor can accept payments from a business entity if the distributor has established that the purchaser, such as the medical director of the facility, is a health care practitioner who is licensed and authorized to use the device in the State where that professional is licensed. State law may restrict who can and who cannot use the device. State law may permit the physician to delegate laser procedures to nurses, physician assistants, and technicians. On the other hand, State law may prohibit the delegation of medical treatment, requiring all laser treatments to be performed by a physician licensed by the Board of Medical Examiners.

A distributor should not sell a laser device to a person who is not authorized to use the device independently or under the supervision of a licensed physician, assuming that supervised use is even permitted under State law.

Andrew,

Thanks for your response...here are answers to your questions.
State: Georgia
Medical Director: Family Practioner/MD Yet Cutera never trained the doctor on the devices. The medical director did not purchase the equipment nor did he sign a prescription for the devices.

To your point below:

"A laser distributor should not sell or lease a device to a person who cannot lawfully use the device. A medical device distributor cannot sell a prescription medical device to a non-physician at that person’s request. Companies that distribute prescription medical devices are not permitted to encourage or to assist a person in providing medical services without a license."

Cutera worked with a laser franchise and was a "strategic partner" with the laser franchise and "told the franchisee, that they could buy the lasers if they had a medical director." Cutera and the laser franchise actively recruited business people to buy these clinics. I know that Cutera worked with this franchise and sold at least 3 clinics to business people. I know at least one clinic closed because they found what they were told by Cutera and the laser franchise to be false...there is a law suit pending.

These are facts...and this is why the post Jeff placed on the website: Is Cutera violating FDA rules" needs to be seriously looked into.

Thanks,

Q