The Food and Drug Administration regulates all medical lasers. Most efficacious aesthetic lasers are classified as medical devices and , as such, must be owned (or leased) by a physician. Yes, some medical devices are legally available to other professional, but these are exceptions.
What is the non-physician treating? There may be a difference between using a light-based device for hair removal and treating a medical condition. The law is clear that only a physician or an appropriate allied health provider can make a medical diagnosis. Diagnosis cannot be delegated by a physician.
However, newer generation products that contain light-based components are federally classified as medical devices.
While it can be argued that nonmedical staff can perform purely aesthetic procedures, such as laser hair removal or tattoo removal, bear in mind that the devices being utilized are still federally classified as medical devices and their use (and ownership) may be limited by that concept.
Nonmedical personnel may make an initial review and listen to the patient’s concerns, but the minute there is any irregularity or subjective complaint from the patient, a physician or appropriate medical provider should be brought in to manage patient care.
“Owning a laser does not give you the legal right to use it.”
It is important to check your own state’s laws. It is also prudent to have good written protocols and to utilize medical personnel rather than simple training a “lay person” to save money.
Here are my state’s guidelines (Regulation No 22, Laser Surgery Guidelines):
Pursuant to Ark. Code Ann. 17-95-202, the practice of medicine involves the use of surgery for the diagnosing and treatment of human disease, ailment, injury, deformity, or other physical conditions. Surgery is further defined by this Board as any procedure in which human tissue is cut, altered, or otherwise infiltrated by mechanical means, to include the use of lasers. The Board further finds that the use of medical lasers on human beings, for therapeutic or cosmetic purposes, constitutes the practice of medicine.Under appropriate circumstances, that being the performing of minor procedures, a physician may delegate certain procedures and services to appropriately trained non-physician office personnel. The physician, when delegating these minor procedures, must comply with the following protocol:
A physician who does not comply with the above stated protocol when performing minor procedures will be considered as exhibiting gross negligence, subjecting the physician to a disciplinary hearing before the Board, pursuant to the Medical Practices Act and the Rules and Regulations of the Board.
- The physician must personally diagnose the condition of the patient and prescribe the treatment and procedure to be performed.
- The physician may delegate the performance of certain tasks in the treatment only to trained non-physician personnel skilled in that procedure.
- The physician must make himself available to respond to the patient should there be any complications from the minor procedure.
- The physician should ensure and document patient records that adequately describe the condition of the patient and the procedure performed, and who performed said procedure.
History: Adopted June 5, 1998; Amended June 2, 2005
Lasers: Aesthetic or Medical?; MedEsthetics, Jan/Feb 2009, pp16-19; Padraic B Deighan, MBA, JD, PhD
Arkansas Medical Board: Arkansas Medical Practices Acts & Regulations (pdf file) – page 57, Regulation No. 22, Laser Surgery Guidelines