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Safety of Children's Toy Laser Products

This guidance addresses children's toy laser products, defined as products primarily used as toys manufactured, designed, intended, or promoted for novelty or visual entertainment use by children under 14 years of age. It excludes laser products used in professional or academic settings.

  1. Ensure laser emissions do not exceed FDA Class I or IEC Class 1 limits
  2. Implement appropriate labeling including IEC Class 1 designation
  3. Obtain necessary product certification for entire toy or removable laser components
  4. Review product marketing, sales channels, and features to determine if product qualifies as children’s toy
  5. Incorporate appropriate safety features, warnings, and instructions
  6. Ensure compliance with both FDA and CPSC regulations
  7. Consider potential misuse scenarios by children in product design
  8. Document compliance with Federal Performance Standards for Laser Products

Key Considerations

Human Factors

  • Products should consider that children may use lasers in unsafe or uncontrolled manner
  • Retinal injuries may go unnoticed and unreported
  • Products should consider supervision by adults who may not recognize dangers

Labelling

  • IEC Class 1 designation labeling is recommended
  • Promotion, advertising, labeling, packaging, and product graphics should be considered in determining if product is a children’s toy

Safety

  • Must comply with Federal Performance Standards for Laser Products
  • Emission levels should not exceed FDA Class I or IEC Class 1 limits
  • Entire toy needs certification unless laser-emitting parts are removable
  • Should incorporate safety features, warnings, and instructions for safe use

Other considerations

  • IEC 60825-1:2007: Safety of laser products
  • 21 CFR 1040.10 and 1040.11: Federal Performance Standards for Laser Products

Original guidance

  • Safety of Children’s Toy Laser Products
  • HTML / PDF
  • Issue date: 2014-12-19
  • Last changed date: 2020-03-24
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiological Health
  • ReguVirta summary file ID: dd47e6da748cc3889951d31d932970c1
This post is licensed under CC BY 4.0 by the author.