Lasers have numerous applications in various aspects of our lives. In the medical field, they are used in general surgery, eye surgery, dental and cosmetic procedures, and more. The FDA regulates the safety of all laser devices. Being aware of what these safety guidelines are has recently become more important especially with the emergence of at home medical laser devices. How do you know the device you’re purchasing is safe? Read on.
In accordance with the Code of Federal Regulations, title 21 (21 CFR) parts 1010, 1040.10, and 1040.11, the FDA requires that manufacturers declare 3 important parameters on any laser device:
Power (in joules or watts)
In Watts or Joules, which you can convert from one to another by a simple equation. Watts = Joules/seconds. For instance, the PaloVia we reviewed recently declares in its specs that maximum output energy is 15mJ, and its pulse duration is 10ms. 15mj/10ms=1.5mW (miliWatt). The FDA states that home devices should never have a power higher than 5mW to avoid eye injury. Lasers used in the clinic have higher powers and precautionary safety measures are always implemented in such settings.
Laser devices are categorized into 1 of 7 classes depending on how dangerous they are to the eyes and skin. This classification is based on a combination of measures including power, wavelength etc. The classification adopts a worst case scenario, in which there is minimal distance from the laser, prolonged exposure, and no protective eyewear. These classes are:
|Class 1 (or I)||Not hazardous. Incapable of producing damage. Exempt from any control measures & surveillance. Example is a laser printer.|
|Class 1M (or IM)||Safe during normal operation. Dangerous if viewed with an optical aid e.g. eye loupe or telescope OR if viewed for an extended time. Example: PaloVia|
|Class 2 (or II)||The aversion response offers enough protection against this class (i.e blinking, looking away). Dangerous if viewed for an extended time. Example is a laser pointer.|
|Class 2M (or IIM)||Safe during normal operation. Dangerous if viewed with an optical aid e.g. eye loupe or telescope OR if viewed for an extended time|
|Class 3R (or IIIR)||Hazardous if viewed directly or with an optical aid. Requires a trained operator.|
|Class 3B (or IIIB)||Hazardous from direct and scattered radiation to eyes and skin. Requires a trained operator. Example is laser light show equipment.|
|Class 4 (or IV)||Hazardous from direct and scattered radiation to eyes and skin. There is also a fire hazard risk. Requires a trained operator. Example: devices used by dermatologists, surgeons etc.|
Lasers with labels of Class 1M, 2M, 3B, or 4, should not be purchased unless they are approved by the FDA. Further, practices using laser Classes 3B and 4 must appoint a “laser protection advisor” and a “laser safety officer”, both of which check up on the devices regularly to ensure their safety.
This number varies widely depending on the targeted chromophore. A chromophore is a target in the skin that gives off a certain color, and this color attracts different laser wavelengths. There are three basic chromphores in the skin: blood, melanin, and water. Lasers that target blood fix broken vessels and rosacea; lasers that target melanin fix hair excess and age spots, lasers that target water are used for skin rejuvenation.
Finally, this following collective excerpt from the FDA website is a very useful summary:
- Look for the following information on the label to make certain that a laser (or a toy that includes a laser) is safe:
- a statement that it complies with Chapter 21 CFR (the Code of Federal Regulations).
- the manufacturer’s or distributor’s name and the date of manufacture.
- a warning to avoid exposure to laser radiation.
- a class designation up to Class IIIa.
- Be aware that the manufacturer of a Class IIIb or IV laser product must obtain permission (also called a “variance”) from FDA before the laser is sold to the public if the laser product:
- is designed, intended, or promoted for surveying, leveling, or alignment (which includes pointing).
- is a demonstration laser product (which includes laser projectors) that is designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition.
- Do NOT buy laser pointers for children or allow them to use them. These products are not toys.
- Do NOT buy any laser pointer that emits more than 5mW output power and does not have the output power printed on the warning label affixed to the pointer.
- Do NOT aim or shine laser pointers at any person, pet, vehicle, or aircraft directly, or through reflection by mirrors or other shiny surfaces.
- In the event of injury, immediately consult your eye doctor.
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H. Bargman. Laser Classification Systems. The Journal of Clinical and Aesthetic Dermatology 2010; 3 (10): 19-20.
S. Parker. Laser Regulation and Safety in General Dental Practice. British Dental Journal 2007; 202: 523-32.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm135680.htm (CFR on the FDA site)