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Laser registration with the FDA of the United States

Common visible light sources, such as the sun or light bulbs, emit a mixture of invisible and visible light like waves. These waves have different lengths and move in all directions. These different "wavelengths" produce different types of light, such as ultraviolet, purple, blue, green, red and infrared.

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     Unlike ordinary light, laser has a specific wavelength, and the expansion of this specific wavelength leads to a focused narrow beam that can be emitted in one direction. The expansion, concentration and directionality of this light are concentrated in a small area, and very high-intensity light can be produced even at a great distance from the laser.

I. FDA registration of laser products

Components of audio, video and computer equipment, such as CD, DVD, Blu-ray, HD (high definition) or other disc players and video recorders;

2. Many barcode readers;

3. Printers, photocopiers, fax machines;

4. Laser Pointers and pens are generally used for demonstration, measurement and positioning.

5. Optical fiber systems for telephone, video and computer networks;

6. It is applicable to material processing operations, such as cutting, welding, engraving or marking systems.


Why do laser products need to be registered with the FDA?


The so-called FDA certification is not strictly speaking a kind of certification. It is a market access control carried out by the FDA agency of the United States on the products under its jurisdiction. Only by obtaining the FDA Accession Number issued by it can one clear customs smoothly and be sold in the US market.

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三、The FDA recognizes four major hazard categories (I to IV) for lasers, including three subcategories (IIa, IIIa, and IIIb). The higher the grade, the more powerful the laser, and the greater the possibility of causing serious injury if used improperly. The II-IV category labels must include a warning symbol. Indicate the grade and output power of the product. For products marked under the classification system of the International Electrotechnical Commission, including approximately equivalent IEC grades.

The output power of the first category of laser products is 1 milliwatt. It won't burn the skin and won't cause a fire. Because eye reflection can prevent some eye damage, this type of laser is not regarded as a dangerous optical device.

2. The output power of Class lla laser products ranges from 1 milliwatt to 5 milliwatts. It won't burn the skin. Under certain conditions, this type of laser can cause blindness and other damage to the eyes.

3. The output power of Class llb laser products ranges from 5 milliwatts to 500 milliwatts. When the power is relatively high, this type of laser product can burn the skin. This type of laser product is clearly defined as being harmful to the eyes, especially when the power is relatively high, it will cause eye damage.

4. The output power of Class IV laser products is greater than 500 milliwatts. Such laser products are bound to cause eye damage. Just like burning the skin and igniting clothes, lasers can ignite other materials.

 

FDA Class Hazards of laser products Product Example
A generation Considered harmless. The danger increases when viewed with optical aids, including magnifying glasses, binoculars, or telescopes. Laser printer
CD player
DVD player
SeNGw reactions; II Direct long-term observation will increase the risk. Observation with optical auxiliary devices increases the risk. Barcode scanner
IIIa receptor Depending on the power and beam area, it may cause instant danger when viewing directly or directly looking at the beam with the naked eye. The risk of injury increases when viewed with optical assistive devices. Laser indicator
Family IIIb Directly observe the direct skin hazards and eye hazards caused by direct light beams. Laser light display projector
Industrial lasers
Research on lasers
IV Contact with direct or reflected light beams can immediately cause skin and eye hazards; there may also be fire hazards. Laser light display projector
Industrial lasers
Research on lasers
Medical equipment lasers for ophthalmic surgery or skin care
 
 
   
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