New Laser, Light, Radiofrequency, and Plasma Device Rules Go Into Effect March 1, 2007

Rules designed to protect patients from unlicensed cosmetic laser procedures

The Medical Quality Assurance Commission has taken an important step to protect patients having medical treatments for hair removal, rosacea, age spots, and similar skin procedures. The new rules set training and professional standards for laser light, radio frequency and plasma devices.

Who is Affected?

The rules apply only to physicians and physician assistants and those licensed professions who are delegated to operate the laser, light, radiofrequency and plasma prescriptive devices. According to the rules, licensed professionals practicing within their professional scope may use such devices under the supervision of a physician or physician assistant.

What are the Requirements?

The rules spell out what is required of physicians and physician assistants who operate these devices, who they can delegate to use them, and the degree of supervision required. The rules require patient evaluations by physicians or physician assistants prior to any treatment and medical records kept.

What Is The Purpose Of The Rule?

The rules defines the laser, light, radiofrequency, and plasma devices as medical devices (a) that use a laser, non-coherent light, intense pulsed light, radiofrequency, or plasma to topically penetrate skin and alter human tissue and (b) are classified by the Federal Food and Drug Administration (FDA) as prescription devices;

The rules apply to a narrow range of devices defined by the federal government as "prescriptive devices." They include devices that use a laser, non-coherent light, intense pulsed light, radiofrequency or plasma to penetrate the skin and alter human tissue. Penetrating the skin or altering human tissues constitutes the practice of medicine.

There are five documents listed below that explain these requirements in more detail.

For more information about the laser rules, see attached

• Frequently asked questions (FAQ)
• The adopted rule proposal
• The Small Business Economical Impact Statement
• The Significant Legislative Analysis
• The Concise Explanatory Statement.

For More Information

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