What Fee Structures And Small Business Reductions Apply To Fda 510(K) Premarket Notifications For Medical Aesthetic Devices? Learn Key Eligibility And Filing Steps.

For an FDA 510(k) submission, the applicable charge is generally a single premarket-notification user fee set annually by FDA. A qualified small business may pay a substantially reduced 510(k) fee, but the exact dollar amount depends on the FDA fiscal year and the applicable fee schedule. The reduction is available to eligible U.S. and foreign manufacturers, including qualifying affiliates in the financial assessment.

The key distinction is between the standard 510(k) fee and the small-business 510(k) fee. Small-business status does not eliminate the 510(k) fee, and it must generally be established with FDA before relying on the reduced rate.

How FDA 510(k) fees are structured

The standard 510(k) user fee

FDA charges a premarket notification user fee for reviewing most 510(k) submissions under the Medical Device User Fee Amendments and related legislation.

The fee is generally due when the 510(k) is submitted. FDA will not begin substantive review until the required payment and submission requirements are satisfied.

The fee schedule changes by fiscal year

FDA publishes medical device user fees for each fiscal year. Therefore, a fee quoted for one year should not be treated as a permanent rate.

The applicable amount is determined by the fee schedule in effect when the submission is filed, subject to FDA’s payment rules.

510(k) submission types

Traditional, Special, and Abbreviated 510(k) submissions are all forms of premarket notification. The applicable FDA user fee should be confirmed against the current fiscal-year schedule rather than assumed from the submission format alone.

A company may also incur separate costs for activities such as testing, clinical work, consulting, translations, or optional third-party review. These are not the same as FDA’s user fee.

Who may qualify for the small-business reduction

The financial threshold

The primary reference identifies the small-business threshold as gross sales and receipts of $100 million or less, calculated across the company’s relevant affiliates.

This assessment is broader than the revenue of a single subsidiary or project entity. A manufacturer should evaluate its corporate structure carefully before applying.

U.S. and foreign manufacturers

The reduction is not limited to U.S.-based companies. Foreign manufacturers may also qualify if they meet FDA’s small-business requirements.

The key issue is the company’s financial qualification, not simply where the manufacturing facility or headquarters is located.

Affiliates matter

FDA’s analysis generally requires consideration of the applicant’s affiliates. A company should not assume that creating a separate legal entity for the aesthetic-device business will make it eligible if related entities must be included in the calculation.

Incorrectly excluding affiliates can result in an invalid qualification or a request for additional documentation.

What the reduction does—and does not—cover

It reduces the FDA submission fee

A qualifying company pays the small-business 510(k) rate rather than the standard rate. The difference can be material, particularly for early-stage manufacturers or companies submitting several devices.

The exact reduced amount must be taken from the current FDA fee schedule for the relevant fiscal year.

It does not waive the fee

Small-business status generally provides a reduced fee, not a complete waiver, for a 510(k) submission.

This distinction is important when preparing a regulatory budget. A company must still reserve funds for the FDA user fee and for the technical work needed to support substantial equivalence.

It does not lower the regulatory standard

The reduction affects the cost of FDA review, not the evidence FDA expects. A small company must still demonstrate that its device is substantially equivalent to a legally marketed predicate device.

FDA may request additional information, performance testing, risk analysis, or clinical data when necessary, regardless of the applicant’s size.

How this applies to medical aesthetic devices

Typical 510(k) devices

Many energy-based aesthetic products—such as certain laser, radiofrequency, light-based, hair-removal, skin-resurfacing, and body-contouring systems—may be regulated as Class II devices and may use the 510(k) pathway.

However, classification depends on the device’s intended use, technological characteristics, and applicable regulation. “Aesthetic” does not automatically mean that a 510(k) is required or available.

New devices and significant modifications

A 510(k) may be required before commercial distribution of a new device, or after a modification to an existing device if the change could significantly affect safety or effectiveness.

Examples can include changes to:

Energy source or output
Device design or operating software
Materials or chemical composition
Manufacturing processes
Intended use or clinical indications
Patient-contacting components

The relevant question is whether the change creates a new question of safety or effectiveness—not merely whether the product has a different commercial name.

Substantial equivalence remains central

The submission must compare the new or modified device with a legally marketed predicate. The manufacturer typically addresses intended use, technological characteristics, performance testing, labeling, and risk considerations.

A reduced fee does not change the need for a credible predicate-device strategy or a technically complete submission.

Understanding the Trade-offs

The fee is only one part of the total cost

The FDA user fee may be modest compared with the cost of developing the submission. Testing, engineering documentation, biocompatibility work, software documentation, labeling, quality-system activities, and regulatory support can represent a larger portion of the budget.

A low 510(k) fee should therefore not be confused with a low overall market-entry cost.

510(k) is not automatically the fastest route

A well-supported 510(k) can be more efficient than a PMA, but review timing depends on submission quality, FDA questions, predicate suitability, and the complexity of the device.

A weak predicate strategy or incomplete testing can create delays that outweigh the initial fee savings.

PMA fees are not the relevant comparison for every device

PMA is generally associated with higher-risk Class III products and requires independent evidence of safety and effectiveness. Many medical aesthetic devices may instead be eligible for 510(k), but that conclusion must be based on classification and intended use.

Manufacturers should not select 510(k) solely because it is less expensive. The device must fit the legal and technical requirements of that pathway.

Small-business qualification requires documentation

A company should complete FDA’s small-business qualification process before submitting the 510(k) if it intends to claim the reduced fee.

The qualification process can require financial information and corporate-affiliate details. Waiting until submission can create payment delays or force the company to address an incorrect fee after filing.

How to Apply This to Your Project

The practical approach is to confirm both the correct submission pathway and the current fiscal-year fee before filing.

If your primary focus is minimizing the FDA payment: Determine whether the applicant and all relevant affiliates meet FDA’s small-business revenue threshold, then obtain the required qualification before submitting the 510(k).
If your primary focus is budgeting the full launch: Treat the user fee as only one cost category and separately estimate testing, documentation, consulting, clinical evidence, labeling, and quality-system work.
If your primary focus is choosing the correct regulatory pathway: Confirm that the device’s intended use, classification, technology, and predicate support a 510(k) rather than assuming that all aesthetic equipment qualifies.
If your primary focus is modifying an existing device: Conduct a documented change assessment to determine whether the modification could significantly affect safety or effectiveness and therefore require a new 510(k).
If your primary focus is avoiding payment problems: Verify the FDA fee schedule in effect for the filing fiscal year and submit the small-business documentation and payment in the manner FDA requires.

The right strategy is to secure small-business qualification early, verify the current FDA fee schedule, and build the broader evidence and compliance budget around the actual device—not just the filing charge.

Summary Table:

Fee Type	Standard Fee	Small Business Fee	Eligibility Criteria
510(k) User Fee	Set annually by FDA	Reduced rate if qualified	Gross sales ≤ $100M (including affiliates)
Qualification Process	N/A	Must apply before submission	U.S. and foreign manufacturers eligible
Additional Costs	Testing, consulting, etc.	Same as standard	Not reduced by fee waiver

Are you ready to navigate the FDA 510(k) process for your aesthetic device? At BELIS, we specialize in professional-grade medical aesthetic equipment and understand the regulatory landscape. Our team can guide you through the fee structure, small business qualifications, and comprehensive submission strategy. Contact us today to ensure a smooth and cost-effective path to market. Get in touch with our experts!