1. Scope of application of regulations
All laser products sold or imported in the United States, including consumer laser devices such as laser pointers, barcode scanners, and laser printers
Overseen by the Center for Devices and Radiological Health (CDRH) under the FDA
II. Laser Classification
The FDA categorizes laser products into five levels based on their hazard levels:
Class I: The highest safety level, with output power typically <0.4µW
Class II / IIa: Output power up to 1mW
Class IIIa: Output power of 1-5mW, laser pointers typically fall into this category
Class IIIb: Output power ranging from 5 to 500mW
Class IV: Output power > 500mW, posing the greatest hazard
Special requirements for laser pointers: The power of laser pointers must not exceed Class IIIa (3R category). In principle, those exceeding this level
are not allowed to be sold on the market.
III. Product Labeling Requirements
The product body must be affixed with a laser warning label that meets the standard, including:
Signal word ("Caution" or "Danger")
Laser class (such as "CLASS IIIa LASER PRODUCT")
Wavelength and maximum power
Specified warning symbol
Manufacturer name, address, production date
Certification statement: It must be marked as "Complies with 21 CFR 1040.10 and 1040.11" or "Complies with 21 CFR Chapter 1, Subchapter J."
IV. Requirements for user manual
Must include:
Detailed installation instructions and operation guides
Clear laser safety warnings (such as "Avoid looking directly at the beam")
Instructions on usage restrictions and potential hazards
Appropriate protective measures
V. Safety design features
Depending on the laser level, the following may be required:
Protective shell
Safety interlock device
Remote control connector
Key switch (Class IIIb and above)
Automatic shutdown mechanism
VI. Certification and Record-filing Process
FDA does not issue traditional "certificates", but instead relies on technical report filing and enterprise registration:
Enterprise registration: Register manufacturer information in the FDA system and obtain an FEI code
Product classification: Determine FDA laser class based on parameters such as wavelength and power
Prepare a laser product report: including technical description, laser parameters, safety protection instructions, quality control documents, etc
Submission for record: Submit reports, label samples, instructions, etc. through the FDA eSubmitter system
Obtain the record number: After approval, the FDA assigns a unique Accession Number, which serves as a compliance certificate and must be
declared during import customs declaration
Class I exemption reminder: Class I products with an output power of less than 1mW and completely enclosed without exposure risk can be
exempted from submitting product reports, but they still need to meet labeling and design safety requirements.
VII. Annual reporting obligation
After obtaining the filing number, the manufacturer must submit an annual report to the FDA, updating information such as sales volume,
manufacturing status, and product design changes. Failure to submit on time may affect the product's access status in the US market.
VIII. Simplified Path for Laser Notice 56
The FDA permits manufacturers to adopt the classification and labeling of the international standard IEC 60825-1 in lieu of the native 21 CFR
requirements under certain conditions. If this path is taken, the label must state: "Complies with FDA laser product performance standards
except for conformance with IEC 60825-1 Edition 3, as described in Laser Notice No. 56."
IX. Important Reminder
The FDA does not issue physical certificates, and any third-party organization claiming to be able to handle "FDA laser certification" is suspected
of false advertising
If there are significant design changes (such as replacing the laser or adjusting the power) after a product has been approved for market entry, a
supplementary report must be resubmitted
During mass production, it is essential to ensure that the actual shipped products are fully consistent with the recorded technical documentation
