Description
Thisguidanceis intended to inform manufacturers of laser products, FDA staff and the public of the Center for Devices and Radiological Health’s (CDRH) current thinking on the safety of children’s toy laser products. Lasers with outputs above certain levels that are operated in an unsafe and uncontrolled manner may cause injury to the user and/or others within range of the laser beam. This is a particular concern for lasers intended for entertainment purposes, especially when intended to be used as toys by children.
Scope & Applicability
Product Classes
4Products subject to emission limits to minimize risk to users.
Category of laser products that may comply with IEC Class 1 limits.
Category of laser products that may comply with IEC Class 1 limits.
Products primarily used as a toy manufactured, designed, intended or promoted for novelty or visual entertainment use by children under 14 years of age.
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
2Basis for determining the class of a removable laser.
Target population for products defined as children's toy laser products.
Identified Hazards
Hazards
2Potential injury caused by lasers.
Injuries caused by laser light that may go unnoticed and unreported.
Related CFR Sections (2)
- 21CFR1040.11§ 1040.11 Specific purpose laser products.
(a) Medical laser products. Each medical laser product shall comply with all of the applicable requirements of § 1040.10 for laser products of its class. In addition, the manufacturer shall:Read full regulation →
- 21CFR1040.10§ 1040.10 Laser products.
(a) Applicability. The provisions of this section and § 1040.11 , as amended, are applicable as specified to all laser products manufactured or assembled after August 1, 1976, except when:Read full regulation →
See Also (8)
- Laser Energy Source (Laser Notice 2) (Status: Final)
- Quality Control Practices for Compliance with the Federal Laser Performance Standard (Status: Final)
- Viewing Optics - Sighting Telescope (Laser Notice 8) (Status: Final)
- Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (Status: Final)
- Identification Labels for Certain Class I Laser Products (Laser Notice 48) (Status: Final)
- User Instruction for Medical Products (Laser Notice 44) (Status: Final)
- Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40) (Status: Final)
- User Instruction Hazard Warnings (Laser Notice 35) (Status: Final)