Microneedling is an elective skin treatment that practices and med spas may offer, alone or with radiofrequency (RF). This guide is for practice owners and front desk teams: what FDA has authorized microneedling devices for, what to avoid in ads, and how to answer the safety questions FDA tells patients to ask.
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1. Know what your device is authorized for
FDA’s microneedling devices page says it has “legally authorized microneedling devices to improve the appearance of facial acne scars, facial wrinkles, and abdominal scars in patients aged 22 years or older”, and that it has only authorized a limited number of devices “for specific uses in specified areas of the face and body.”
Each device has its own indications. For example:
- One device (K252591) is cleared only to improve the appearance of facial acne scars in adults aged 22 or older.
- Another (K233709) is cleared for wrinkles in named facial areas in Fitzpatrick skin types I to III, and for facial acne scars in skin types I to IV.
- Look up your device in FDA’s 510(k) database (product code QAI) and keep its indications on file. Advertise only the uses, areas and skin types it covers.
- FDA notes that some devices it authorized were not studied in people with darker skin types. Do not promise results for every skin type unless your device’s indications support it.
2. Do not advertise microneedling as a way to deliver PRP, serums or drugs
FDA’s page says microneedling devices “are not approved for delivery of cosmetics, topical medications (for example, creams, ointments, gels), vitamin solutions, drugs, or blood products (for example, platelet-rich plasma (PRP)) into the skin.” The device classification in 21 CFR 878.4430 also “does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.” FDA adds that the risks of off-label uses, and of combining microneedling with other products, are not known.
- Avoid ad copy that says microneedling “infuses”, “drives in” or “delivers” PRP, growth factors, exosomes, vitamins or serums.
- If your providers combine treatments, have your medical director and counsel review how you describe it before it goes in an ad or on your site.
- Keep claims within labeling; see FDA approved or FDA cleared.
3. Treat RF microneedling as a medical procedure in your marketing
In an October 2025 safety communication, FDA said it is aware of reports of serious complications with RF microneedling for aesthetic skin procedures, “including burns, scarring, fat loss, disfigurement, and nerve damage”. It told patients that “RF microneedling is a medical procedure, not a cosmetic treatment”, and to seek care from a licensed provider with training and experience who can say which device they plan to use.
- Avoid “no risk”, “no downtime”, “painless” and “safe for everyone”.
- Name the device you use when patients ask, and be ready to say who performs the treatment and what training they have.
- Have a written plan for complications, as FDA’s provider guidance recommends, and tell staff how to help a patient who calls with a problem.
4. Be ready for the questions FDA tells patients to ask
FDA’s page recommends that patients ask about the provider’s training and experience, how the device is cleaned between patients, and whether a new needle cartridge is used for each patient and each session. It says re-use of the cartridge is unsafe even if it is cleaned. Give the front desk honest answers:
- Do you use a new cartridge? Say yes only if it is your practice’s written policy for every patient and every session.
- Who does it, and what training do they have? Describe staff by their real credentials.
- Is it right for me? “The provider decides at the consultation and will ask about your health history and medications.” FDA lists conditions that may make it unsuitable, such as pregnancy, blood thinners, active skin infections and isotretinoin in the past 6 months; that screening belongs to the provider.
- How many sessions? FDA notes more than one procedure may be needed. Say the provider will recommend a plan.
Use the new patient phone script for the rest of the call, and book the consultation while the caller is on the line.
5. Price, photos and tracking
- If you advertise a discount or package, follow advertising prices and specials and memberships and packages.
- Before-and-after photos need written authorization and honest comparisons; see before-and-after photos.
- Track microneedling requests separately from other skin treatments, from request to consultation to first treatment.
Where MediLeadGen fits
MediLeadGen sends practices requests from people interested in cash-pay elective treatments. Each request goes to one practice only, with the person’s consent naming that practice, at a fixed price per delivered request.
See how it works for practices
Questions practices ask
How do we get more microneedling patients?
Advertise only the uses your device is authorized for, avoid drug or PRP delivery claims, be open about who treats and how equipment is handled, answer the first call quickly, and book the consultation on that call.
What has FDA authorized microneedling devices for?
FDA says it has authorized microneedling devices to improve the appearance of facial acne scars, facial wrinkles and abdominal scars in patients aged 22 or older. Each device has its own indications, so check yours in the 510(k) database.
Can we advertise microneedling with PRP?
Be careful. FDA says microneedling devices are not approved for delivery of drugs, vitamin solutions or blood products such as PRP into the skin, and that the risks of combining microneedling with other products are not known. Have counsel and your medical director review any such wording.
What did FDA say about RF microneedling?
In October 2025 FDA said it is aware of reports of serious complications with RF microneedling for aesthetic skin procedures, including burns, scarring, fat loss, disfigurement and nerve damage, and that RF microneedling is a medical procedure, not a cosmetic treatment.
General information for practice teams, not legal or clinical advice. Check your device indications, state scope-of-practice and supervision rules, and your advertising with counsel and your medical director. Last reviewed October 2026.
More resources
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