Laser Treatment Classifications in Cosmetic Medicine
The invention of the laser has led to many advancements in the electronic and medical device industries. In the aesthetic arena, new and improved lasers are entering the market every few months. This rapid development is leaving the classification criterion to continually be redefined. Therefore, the following information is deemed to be a guideline and is not considered to be a definite and thorough description.
Lasers in use by medical practitioners typically have low outputs of energy and power, and are thus placed in ANSI (American National Standards Institute) Class 2 category. Another important organization is the LIA (Laser Institute of America). The majority of medical lasers fall into the ANSI Class 3 or 4 categories with most surgical lasers being in ANSI Class 4. Most medical and/or surgical lasers are classified by the FDA (Food and Drug administration) as Class II or Class III medical devices.
Class 1: These types of low power lasers are not considered to pose any hazards when operated according to normal conditions and includes lasers which are completely enclosed such as CD players, fiber-optics devices, and printers. These devices cannot have emissions exceeding the maximum permitted exposure (MPE) under any conditions are considered to be class 1 systems.
Potential dangers can occur during the repair of such devices since the laser is outside of the enclosure. Warning labels are required for this class inside the unit or underneath the cover.
Class 2a Lasers: Few lasers qualify for this class of low-power, visible light lasers. Lasers in this class do not pose a threat if the beam of light is directly viewed for periods of time less than 16 minutes or so. Visible light lasers with a total output power less than 1 milliwatt, but greater than a few microwatts.
Class 2: This class of lasers includes visible light lasers that are intense enough that viewing the beam into a human eye can cause the normal “aversion response”. An aversion response is when the eyelids close, or the head moves in order to avoid the light. It can occur within 0.25 seconds and includes the blink reflex time.
Class 3a: This includes those lasers emitting ultraviolet or infrared light as well as visible light. All devices within the Class 1 AEL (Allowed Exposure Level) with laser output between .18μm and 1mm fall in this class. (Common Laser pointers are class 3a laser devices.)
Class 3b: These include the same spectrum as class 3a, but increase the output levels to that of Class 2 AEL.
Class 4 Lasers: This class of lasers includes any that exceeds the Class 2 AEL. Most every laser that produces an excess of 0.5 watts is in this class. Laser hair removal, photofacials, laser resurfacing… these are all class 4 lasers and are classified as medical devices that must be used or overseen by a physician.
