FDA Laser

FDA laser products and instruments are radiation-emitting products and subject to FDA approval. The word laser stands for Light Amplification by the Stimulated Emission of Radiation. One basic type of laser consists of a sealed tube, containing a pair of mirrors, and a laser medium that is excited by some form of energy to produce visible light or invisible ultraviolet or infrared radiation.

Ordinary sources of visible light, such as the sun, emit a mixture of invisible and visible light as waves. These waves have varying wavelengths and move in all directions at the speed of light. The different wavelengths produce ultraviolet, violet, blue, green, yellow, red, and infrared light.

Unlike ordinary light, laser light has a specific wavelength and amplification of this wavelength results in a narrow, focused beam of light that is emitted in one direction. The amplification, focus, and singular direction of the light concentrated in a small area can create a very high intensity light even at large distances from the laser.

In order to reap the benefits of lasers, the risks of laser exposure need to be managed. The FDA recognizes four major hazard classes (I to IV) of lasers. They are listed as follows.

• Class I – considered non-hazardous unless viewed with optical aids such as a magnifier

o   Laser printers

o   CD players

o   DVD players

• Class II, IIa – hazard increases if viewed directly for a long time or with optical aids

o   Bar code scanners

• Class IIIa – depending on power and beam area, can be hazardous when viewed directly or when staring directly at the beam with one’s eye. Risk increases with optical aids.

o   Laser pointers

• Class IIIb – immediate skin hazard from direct beam and immediate eye hazard when viewed directly.

o   Laser light show projectors

o   Industrial lasers

o   Research lasers

• Class IV – immediate skin hazard and eye hazard from exposure to either the direct or reflected beam; may also present a fire hazard.

o   Laser light show projectors

o   Industrial lasers

o   Research lasers

o   Lasers to perform LASIK eye surgery

Manufacturers of electronic radiation emitting products sold in the US are responsible for compliance with FFDCA regulations governing electronic product radiation control. The purpose is to protect the public health and safety from electronic product radiation. The FDA laser program will:

• Develop and administer performance standards for electronic products.
• Plan, conduct, coordinate, and support research, development and training to minimize the emissions of and the exposure of people to unnecessary electronic product radiation.
• Study and evaluate emissions of and conditions of exposure to electronic product radiation and intense magnetic fields.
• Develop, test and evaluate the effectiveness of procedures and techniques for minimizing exposure to electronic product radiation.
• Consult and maintain a liaison with the:

o   Secretary of Commerce

o   Secretary of Defense

o   Secretary of Labor

o   Atomic Energy Commission

o   Other appropriate Federal departments

• The liaison is for the programs of testing and evaluating electronic product radiation and the development of performance standards to control such radiation emissions.

The FDA laser is subject to FFDCA regulations. As a medical device, a laser needs FDA approval.

Written by: Margaret Stenerson

10 8 2010