Notices to the Laser Industry

Information

Description

Products that use laser energy come in many sizes, shapes and forms. What they have in common is a laser which stores energy from a source, such as, an electrical discharge, chemical reaction or powerful optical illumination that releases the energy as light.

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.

LEDs (Light Emitting Diodes) are different from laser diodes and are not subject to the Federal laser product performance standard.

An ordinary source of visible light, like the sun or a light bulb, emits a mixture of invisible and visible light like waves. These waves have varying lengths and move in all directions. These differing "wavelengths" produce different types of light, such as ultraviolet, violet, blue, green, red and infrared.

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

Uses

  • Components of audio, video and computer equipment such as CD, DVD, Blue Ray, HD (High Definition), or other optical disk players and recorders
  • Many bar code readers
  • Printers, copiers, FAX machines
  • Laser pointers and pens commonly used for presentations, surveying, and positioning
  • Fiber optic systems for telephone, video, and computer networks.
  • Applied to material processing operations such as cutting, welding, engraving, or marking systems.
  • Applications in laboratories for research, measurements, and optical sources.
  • Lasers specifically designed for use in medical procedures.
  • Lasers specifically designed and promoted for laser light shows, entertainment, advertising, etc.

Risks/Benefits

Laser products improve the quality, precision, accuracy, security and reliability of many forms of products, materials, communications and data handling. In order to realize the benefits of lasers, the risks of laser exposure must be managed.

Laser Hazard Classes

The FDA recognizes four major hazard classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). The higher the class, the more powerful the laser is and the greater the potential to pose serious injury if used improperly. The labeling for Classes II–IV must include a warning symbol that states the class and the output power of the product. Roughly equivalent IEC classes are included for products labeled under the classification system of the International Electrotechnical Commission.

Class FDA Class IEC Laser Product Hazard Product Examples
I 1, 1M Considered non-hazardous. Hazard increases if viewed with optical aids, including magnifiers, binoculars, or telescopes.
  • laser printers
  • CD players
  • DVD players
IIa, II 2, 2M Hazard increases when viewed directly for long periods of time. Hazard increases if viewed with optical aids.
  • bar code scanners
IIIa 3R Depending on power and beam area, can be momentarily hazardous when directly viewed or when staring directly at the beam with an unaided eye. Risk of injury increases when viewed with optical aids.
  • laser pointers
IIIb 3B Immediate skin hazard from direct beam and immediate eye hazard when viewed directly.
  • laser light show projectors
  • industrial lasers
  • research lasers
IV 4 Immediate skin hazard and eye hazard from exposure to either the direct or reflected beam; may also present a fire hazard.
  • laser light show projectors
  • industrial lasers
  • research lasers
  • medical device lasers for eye surgery or skin treatments

There are laws, regulations, and standards that require engineering controls and risk communication to aid in the management of the biological hazards associated with each laser class. However, no controls are completely effective if lasers are improperly used.

Laws, Regulations, and Standards

Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control.

Manufacturers of laser products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005:

  • 1000 - General
  • 1002 - Records and Reports
  • 1003 - Notification of defects or failure to comply
  • 1004 - Repurchase, repairs, or replacement of electronic products
  • 1005 - Importation of electronic products

In addition, laser products must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1040:

  • 1010 - Performance standards for electronic products: general
  • 1040.10 - Laser products
  • 1040.11 – Specific purpose laser products

Manufacturers of laser products can request an alternate means of providing radiation safety; this is called a Variance:

  • 1010.4 – Variances from Standards

The document Exemptions from Electronic Product Regulations has been assembled to simplify the process of finding all the exemptions provided for in the Code of Federal Regulations (CFR) Parts 1000-1050 and those granted by an agency letter or Laser Notice.

Laser products that are used for medical applications must also comply with the medical device regulations. For more information, see: Overview of Device Regulation.

Laser products designed and promoted for the production of laser light shows, displays, advertising, etc. are demonstration laser products subject to the requirements of 21 CFR 1040.11(c).

Required Reports for the Laser Products and Instruments Manufacturers or Industry

  • Guide for Preparing Product Reports on Lasers and Products Containing Lasers
  • Guide for Preparing Annual Reports on Radiation Safety Testing of laser and Laser Light Show Products
  • FDA eSubmitter

Industry Guidance - Other Industry Focused Documents

  • Variance Application Process
  • Minimizing Risk for Children's Toy Laser Products - Guidance for Industry and Food and Drug Administration Staff (PDF - 59KB)
  • Federal Register - Laser Products; Proposed Amendment to Performance Standard
  • Compliance Guide for Laser Products
  • Frequently Asked Questions Regarding the Laser Notice 53 - Guidance for Industry and FDA Staff - Approval of Alternate Means of Labeling for Laser Products (issued March 23, 2007)
  • Medical Lasers
  • Date of Manufacture Label on Radiation-Emitting Consumer Electronics
  • Exemptions From Electronic Product Regulations
  • Quality Control Practices for Compliance with the Federal Laser Product Performance Standard (PDF - 1.1MB)
  • Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling

Other Resources

  • Proposed Rule - Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser Products and Ultrasonic Products
  • Records and Reporting (Radiation-Emitting Products)
  • Importing and Exporting Electronic Products
  • Getting a Radiation Emitting Product to Market
  • Important Information for Laser Pointer Manufacturers
  • Board of Laser Safetydisclaimer icon

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