1、 Core concept: FDA does not 'certify', but mandates registration and reporting
The FDA does not provide "certification certificates" or "approval letters" similar to CE for laser toys exported to the United States. The regulatory
mode is a mandatory registration+product report+annual report system. Products that have not completed registration or obtained an Accession
Number will be refused clearance by US Customs.
2、 Applicable regulatory framework
Laser toys are regulated by the CDRH (Center for Devices and Radiological Health) under the FDA, with core regulations including:
21 CFR 1040.10- General Performance Standards for Laser Products (Classification, Labeling, Safety Protection)
21 CFR 1040.11- Specific purpose laser products (such as demonstration lasers)
21 CFR 1010.2/1010.3- Requirements for Certification and Identification Labels
21 CFR 1002.10- Product Reporting and Record Keeping Requirements
3、 Special definition of children's toy laser products
The FDA currently does not explicitly define "children's toy laser products" in regulations, but the CDRH guidance document defines it as products
primarily intended for use as toys, manufactured/designed/intended for novelty or visual entertainment for children under 14 years of age. The criteria
for judgment include:
Whether there are children's play scenes or cartoon images in packaging, advertising, and labeling
Is it sold through channels aimed at children, such as toy stores
Are the features of the product itself attractive to children
Typical examples include laser sights on toy guns, glowing gyroscopes, handheld "lightsaber" lasers, indoor laser projection entertainment devices, etc.
4、 Classification of laser safety levels
The FDA classifies laser products into the following levels based on achievable emission limits, and misclassification can result in the report being returned:
Class I: Harmless level, laser completely enclosed inside the product (such as laser printers, CD players)
Class II/IIa: Low power visible light, blink reflection provides protection (such as barcode scanners)
Class IIIa: Direct viewing of a beam of light may cause eye damage, typically with a power of 1-5 mW (such as a laser pen)
Class IIIb: Acute harm to skin and eyes from direct exposure, power range 5-500 mW
Class IV: High power, can cause serious injury from direct or reflected radiation, and may even trigger a fire, with power>500 mW
5、 Safety recommendations for children's toy laser products
Although formal regulations are still being developed, the FDA strongly recommends that manufacturers control the output power of children's toy
laser products within the FDA Class I or IEC Class 1 emission limits. Exceeding this limit, the laser may cause eye damage to the user or surrounding
personnel when operated uncontrollably by children.
6、 Labeling and identification requirements
The product must have a permanently fixed, English written, and clearly visible label, which includes at least:
Certification Declaration Label
"Complies with 21 CFR 1040.10 and 1040.11"
Or (if tested according to IEC standards):
"Complies with FDA performance standards for laser products except for conformance with IEC 60825-1 Ed.3., as described in Laser Notice No 56"
Warning labels (by level)
Class II：LASER RADIATION – DO NOT STARE INTO BEAM
Class IIIa：LASER RADIATION – AVOID DIRECT EYE EXPOSURE
Class IIIb：LASER RADIATION – AVOID DIRECT EXPOSURE TO BEAM
Class IV：LASER RADIATION – AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION
Identification label (must include)
Manufacturer's name and address
Manufacturing location
Manufacturing year and month (four digit year)
Laser medium or emission wavelength
Maximum output power
7、 Registration and Product Reporting Process
Step 1: Enterprise Registration
Register enterprise information in the FDA system and obtain FEI code (Facility Establishment Identifier).
Step 2: Submit Product Report
Submit laser product reports online through the FDA eSubmitter system, including product descriptions, technical documents, test data, label
samples, etc.
Step 3: Obtain the storage number
After FDA approval, a confirmation letter will be issued and a unique Accession Number will be assigned, which is a key credential for the product
to enter the US market legally.
8、 US Agent Mandatory Requirement
All non US domestic manufacturers must designate an agent located within the United States. The agent is responsible for receiving FDA notifications,
cooperating with market inspections, and conducting defect investigations. Without a US agent, registration application cannot proceed.
9、 Annual reporting obligation
Obtaining an entry number is not a one-time solution. Manufacturers must submit their annual report for the previous year to the FDA before September
1st each year, which includes:
The quantity of products produced in that year
Design change situation
Quality control test results
Failure to submit on time may result in the invalidation of the storage number, directly affecting the subsequent batch customs clearance.
10、 Design changes need to be reported again
After the product is launched, if there are significant changes to the core design such as laser type, output power, optical system, etc., a new
product report must be submitted to the FDA for review. Even minor changes need to be detailed in the annual report to ensure continued
compliance with safety standards.
11、 Import customs clearance documents
When the product enters the United States, the importer needs to submit FDA Form 2877 (Declaration Form for Imported Electronic Radiation
Products) to the customs, listing manufacturer information, origin, product description, model, etc., and declaring compliance with radiation
control standards.
12、 Relationship with IEC 60825-1
The FDA recognizes the IEC 60825-1 standard, but only as a partially equivalent alternative. If manufacturers test according to IEC standards, they
still need to meet FDA specific requirements, especially:
21 CFR 1010.2 (Certification Label)
21 CFR 1010.3 (Identification Labels)
21 CFR 1040.10/1040.11 clauses beyond the scope of IEC
In addition, there are no levels directly corresponding to IEC Class 1M and 2M in the FDA classification system, so manufacturers should not design
solely based on IEC 1M/2M parameters and ignore FDA's independent evaluation.
Contact phone number: 19925421523
