Guidance and Considerations for FDA Registration of Laser Products for Export to the United States
The sale and use of any laser product require FDA laser registration to ensure product safety and compliance.
(1) Definition
Products using laser energy come in various sizes, shapes, and forms. Their common feature is the laser, which stores energy from a source such as an electrical discharge, chemical reaction, or intense optical illumination, releasing this energy as light. LASER stands for Light Amplification by Stimulated Emission of Radiation. A basic type of laser consists of a sealed tube containing a pair of mirrors and a laser medium excited by some form of energy to produce visible or invisible ultraviolet or infrared radiation. LEDs (Light Emitting Diodes) differ from laser diodes and are not subject to federal laser product performance standards.
Different models of laser products can be registered together, provided they use the same laser head; if different laser heads are used, separate registrations are required.
(2) Common Laser Products and Classifications
FDA Class IEC Class Products
I 1, 1M Laser printers, CD players, DVD players
IIa, II 2, 2M Barcode scanners
IIIa 3R Laser pointers
IIIb 3B Laser show projectors, industrial lasers, research lasers
IV 4 Laser show projectors, industrial lasers, research lasers, medical device lasers for eye surgery or skin treatment
(3) Documents Required for FDA Registration of Laser Products
1. FDA registration application form for laser products
2. IEC/EN 60825 test report.
(4) Considerations
1. FDA laser products have labeling requirements, including relevant laser warning statements.
2. Upon completion of registration, an Accession Number (registration number) will be issued.