Laser Products and Instruments

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.

The biological effects of laser exposure can be predicted so that lasers can be placed in one of four major hazard categories called Classes. The risk of injury from lasers increases from Class I (non-hazardous) to Class IV (severe hazard).

Class	Laser Hazard	Product Examples
I	Laser usually contained within the product and considered non- hazardous.	Laser printers CD players DVD players
II IIa	Visible laser or laser system that cannot cause eye damage unless viewed directly for an extended period of time, or with magnifiers, binoculars, or telescopes.	Bar code scanners
IIIa           IIIb	Laser that normally does not present a risk of injury if viewed momentarily with an unaided eye, but may present a greater risk if viewed using magnifiers, binoculars, or telescopes.     Laser can cause eye damage if viewed directly	Laser pointers           Laser light shows Industrial lasers Research lasers
IV	Laser may cause severe eye injury with short duration exposure to the direct or reflected beam. May also cause severe skin damage and present a fire hazard.	Laser light shows Industrial lasers Research lasers

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, & 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

Laser products that are used for medical applications must also comply with the medical device regulations. For more information, see: Getting to Market with a Medical Device.

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).

Industry Guidance

CDRH provides guidance to laser manufacturers in the form of Laser Notices, Forms, and other documents.

Submission/Reporting Forms

CDRH provides reporting forms to laser manufacturers to assist them with preparation of product and other reports or submissions.

• CeSub Electronic Submissions Program

If you want to submit using the FDA electronic submissions software (eSubmitter), click on the link above to download the application.  Furthermore, to be able to submit your reports directly through the FDA electronic submissions gateway, you should start the FDA Electronic Submissions Gateway setup process now by following the instructions given on:  http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm

If you want to submit hard copies of reports, please follow the instructions below:

• Reporting Guide - Radiation Safety Product Report for Laser Products, September 1995
• Reporting Guide - Annual Reports, Revised September 1995

Other Guidance

The FDA regulates radiation emitting products.

Here are some useful links and documents in Portable Document Format (PDF) that are viewable with Adobe Reader:

• Compliance Guide for Laser Products - PDF file
• Alternate Labeling Information
• Date of Manufacture Label for Electronic Products Subject to Radiation Standard
• Quality Control Practices for Compliance with the Federal Laser Product Performance Standard - PDF file
• Tabulated Values of Accessible Emission Limits for Laser Products – PDF file

 Other Resources

 The Center for Devices and Radiological Health (CDRH) in the Food and Drug Administration works to protect public health, develops standards and regulations, enforces laws, and educates the public regarding lasers. These CDRH resources help consumers make informed decisions about lasers:

• Regulated Industry: Reports and Recordkeeping
• Regulated Industry: Imports & Exports
• Frequently Asked Questions about Lasers
• Getting Your Product to Market (Frequently Asked Questions)
• Important Information for Laser Pointer Manufacturers
• Consumer Safety Alert: Internet Sales of Laser Products