Accession Numbers - More than a Laser Buying Trick - It's the LAW

Certifying the True Manufacturer of a Laser: Why the FDA Accession Number Matters

In the rapidly growing market for CO₂, fiber, and galvo laser systems, buyers are often faced with a confusing array of brands, resellers, and “manufacturers” who may or may not be the actual origin of the machine. A critical tool in cutting through this fog is the FDA Accession Number. This number is not simply a bureaucratic label—it is the legal certification that ties a laser product back to its true manufacturer or importer of record. Understanding how it works is essential for both compliance and consumer protection.

 
Background: FDA Oversight of Lasers
In the United States, laser products fall under the jurisdiction of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). Specifically, the regulatory framework is found in:

21 CFR 1040.10 – Performance standards for laser products.
21 CFR 1040.11 – Special requirements for certain classes of laser products.
These rules require manufacturers and importers of Class II–IV lasers to incorporate safety features such as emission indicators, protective housings, and labeling. Equally important, they must submit a Laser Product Report to FDA before the product is introduced into U.S. commerce.

 What is an Accession Number?

When a Laser Product Report is filed, the FDA issues an Accession Number. This is a unique reference code that proves the report was received and logged by the agency. The Accession Number does not itself approve the product, but it provides the traceability that regulators and consumers can use to confirm that a product has been properly reported.

According to FDA guidance:

“The manufacturer of a laser product is required to submit a product report in accordance with 21 CFR 1002.10, and such reports are assigned an accession number for reference purposes.”
– 21 CFR 1002.10; FDA CDRH Electronic Product Radiation Control Program
 
Why the Accession Number Identifies the True Manufacturer
The key point is that the Laser Product Report must be submitted by the party responsible for introducing the laser into U.S. commerce—whether that is the overseas OEM or a U.S.-based importer relabeling the machine. The Accession Number therefore reveals:

The legal manufacturer or importer of record.
The model(s) and classification covered.
The date of filing and compliance claims.
This means that if a reseller is presenting itself as a manufacturer, the Accession Number can expose whether the real filing was done by another entity overseas.

Legal Requirement for Disclosure

Under 21 CFR 1010.2 and 1010.3, manufacturers are required to certify that each laser product complies with applicable performance standards and to provide a certification label. The regulations further state that manufacturers must maintain records of compliance testing and make this information available to the FDA.

While the Accession Number itself is not required to appear on the product label, the manufacturer or importer must provide it upon request. In practice, if a consumer, distributor, or regulator asks for the Accession Number, the responsible party is obligated to disclose it as proof of compliance.

 
Practical Implications for Buyers

For consumers and commercial buyers, asking for the FDA Accession Number is the most straightforward way to cut through marketing noise and verify legitimacy.

If the number traces to a foreign OEM: the “brand” may be just a reseller.
If the number is missing or withheld: the machine may not be certified for U.S. sale.
If the number ties to the brand itself: then the company is the importer of record and bears compliance responsibility.
 
Conclusion
The FDA Accession Number is more than an administrative code—it is the buyer’s most powerful tool for certifying the true manufacturer of a laser. By anchoring each machine to a filed report under 21 CFR 1002.10, 1040.10, and 1040.11, it forces transparency in a market often clouded by resellers and re-branding. For those serious about compliance and safety, always request the Accession Number, and verify it against the FDA’s public databases.

 
References
21 CFR 1002.10 – Product Reports.
21 CFR 1040.10 – Performance Standards for Laser Products.
21 CFR 1040.11 – Specific Purpose Laser Products.
21 CFR 1010.2 – Certification of Compliance.
FDA CDRH: Electronic Product Radiation Control Program