How does this affect Laser Jammers?
Product Specific Questions
Q31) Are LEDs or IPLs subject to the laser regulations and reporting?
A) Neither Light Emitting Diodes (LEDs) nor Intense Pulsed Light sources (IPLs) meet the definition of a laser, namely:
21 CFR 1040.10(b)(19) Laser means any device that can be made to produce or amplify electromagnetic radiation at wavelengths greater than 250 nm but less than or equal to 13,000 nm or, after August 20, 1986, at wavelengths equal to or greater than 180 nm but less than or equal to 1.0*106nm primarily by the process of controlled stimulated emission.
Since they do not meet the definition of a laser as the source of the light (and assuming the products do not otherwise incorporate a laser), they are not subject to the laser standard. There is no existing FDA performance standard for Light emitting diodes or Intense Pulsed Light products. They are not subject to Product or Annual reports under 21 CFR 1002. However, as they are radiation-emitting products, the manufacturers of these products would still be subject to the general requirements in Title 21 CFR 1000 through 1005, specifically, accidental radiation occurrence notifications and notifications of defect, 21 CFR 1003 & 1004.
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).
ClassLaser HazardProduct ExamplesClass I -Laser usually contained within the product and considered non- hazardous. Laser printers
DVD players II
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
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 light shows
Class 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