Key takeaways
- The FDA has authorized microneedling devices for facial acne scars, facial wrinkles and abdominal scars in adults 22 or older; other uses are off-label.
- Microneedling devices are cleared or granted, not FDA-approved, and they are not approved to deliver serums, PRP or exosomes into the skin.
- Expect a series of sessions and a slow clock: full results usually take several months, and they fade as the body loses collagen.
- No national session price was readable when this page was researched, so compare the full plan price, the single-session price and each add-on.
- Ask whether a new needle cartridge is used for each patient and each session, and who performs the treatment under what license.
What is microneedling and how does it work?
Microneedling — also called collagen induction therapy — uses a device studded with many small needles, tips or pins that are repeatedly inserted into and removed from the skin.
The FDA describes the tools as rollers, stamps or pen-shaped devices, often motorized, and notes that in some motorized devices the practitioner can adjust and control the depth and speed of penetration.
The American Academy of Dermatology (AAD) calls microneedling minimally invasive and says it works by stimulating the body to make collagen, which is where the name collagen induction therapy comes from.
Microneedling devices are regulated as Class II medical devices under 21 CFR 878.4430, product code QAI.
The first device the FDA authorized through its De Novo pathway was the SkinPen Precision System, granted on March 1, 2018.
Word choice matters here.
Microneedling devices are medical devices that the FDA has cleared or granted, not drugs it has approved — the FDA's own phrase is that it has "legally authorized" specific microneedling products for specific areas of the body.
Pages that call the treatment "approved" are using the wrong term.
The authorization is narrow.
The FDA has authorized microneedling devices to improve the appearance of facial acne scars, facial wrinkles and abdominal scars in patients aged 22 or older.
SkinPen Precision's own authorization is narrower still: a prescription-use device to improve the appearance of facial acne scars in adults aged 22 years or older, and it is not intended to deliver cosmetics, drugs or biologics into the skin.
Needle depth has studied limits, too.
In the SkinPen study, needle depths above 1.5 mm were not evaluated for safety or effectiveness, even though the device can be set up to 2.5 mm.
What does microneedling treat, and who is a good candidate (and who isn't)?
The FDA's authorized list is short: facial acne scars, facial wrinkles and abdominal scars, all in patients aged 22 or older.
A microneedling plan aimed at anything else — stretch marks, large pores, melasma, hair loss or the under-eye area — is an off-label use of the device.
Off-label means the FDA has not reviewed that use; it is not forbidden and it is commonly done, but it is not an authorized indication.
Dermatologists do use microneedling more broadly.
The AAD lists acne scars, dark spots, large pores, melasma, sagging skin, scars from surgery or injury, stretch marks, uneven skin texture and tone, and wrinkles and fine lines as conditions dermatologists use it for.
That list is clinical practice, and not every item on it is an FDA-authorized indication.
For acne scars specifically, the AAD adds a caution: effective treatment depends on the scar type, because ice pick scars need different treatment than rolling scars.
A 2018 review in Dermatologic Surgery concluded that microneedling is a safe, minimally invasive and effective aesthetic treatment for acne and other scars, wrinkles and stretch marks, with quick recovery and limited side effects — a conclusion that also covers uses beyond the FDA's authorized list.
Who is not a candidate?
The FDA's patient list is long.
The agency says microneedling may not be suitable if you:
- have a bleeding or clotting disorder, or take blood thinners, including low-dose aspirin
- have immune suppression or uncontrolled diabetes
- have an active skin infection, hepatitis or HIV
- have eczema, psoriasis, vitiligo or an autoimmune disease
- have an active facial rash or a cold sore outbreak
- take isotretinoin now or have taken it in the past 6 months
- have a history of keloids
- have actinic keratoses, warts or moles in the treatment area
- have a tan or planned sun exposure in the next two weeks
- are having cancer treatment
- are pregnant or breastfeeding
- are allergic to stainless steel or anesthetics
The AAD's version of the list overlaps but is not identical.
It says microneedling usually should not be done in people who heal poorly, have or had keloids, are immunosuppressed, are being treated for skin cancer in the area, or are receiving radiation — and that treatment should be postponed for a tan or recent sun, a skin infection, painful or pus-filled deep pimples, or isotretinoin use.
On isotretinoin the two sources disagree, and it is worth knowing both figures.
The FDA's list covers isotretinoin taken within the past 6 months; the AAD's page says at least one month must have passed since the last pill.
Ask any provider you consult which window they follow and why.
Skin tone deserves its own note.
The FDA flags darker skin types because of the risk of the skin darkening or lightening after the procedure, and notes that some FDA-authorized devices were not studied in darker skin types.
The AAD, by contrast, describes microneedling done by a dermatologist as minimally invasive and safe for every skin tone.
Read the two together: one is the agency's caution about pigment risk and device-by-device study gaps, the other a specialty society's overall position.
FDA patient list
- Isotretinoin now or within the past 6 months
- Flags darker skin types for risk of darkening or lightening
- Some authorized devices were not studied in darker skin types
AAD guidance
- At least one month since the last isotretinoin pill
- Postpone for a tan, recent sun or a skin infection
How much does microneedling cost at a med spa?
Start with what we could not confirm: a national price for a microneedling session.
The American Society of Plastic Surgeons' 2025 procedural statistics report publishes no fee table, and RealSelf's microneedling cost page blocked our access, so no tier-1 or tier-2 national figure was readable when this page was researched.
Treat any single "national average" you see quoted for microneedling with caution.
What we can describe is the plan structure.
Microneedling plans are built as a series of sessions — for acne scars, the AAD describes 3 to 5 treatments spaced 2 to 4 weeks apart, and Cleveland Clinic says most people need multiple treatments — so when you ask a med spa for a price, ask what the full plan costs, what a single session costs if you stop after one, and what each add-on costs.
The add-ons are where the bill grows. Platelet-rich plasma (PRP) is one: blood is drawn from your own body, spun in a centrifuge to separate the platelet-rich plasma, and the PRP is applied during needling — the treatment behind the "vampire facial" name.
The AAD estimates cosmetic PRP sessions at $250 to $1,500 each, not covered by insurance — a dated estimate from the AAD's own page, not a med spa price survey.
Exosome serums are another add-on you may be offered.
The FDA's position is worth reading before you pay for either: microneedling devices are not approved for delivering cosmetics, topical medications, vitamin solutions, drugs or blood products such as PRP into the skin, and the FDA said in its December 2019 safety notification that it has approved no exosome products.
The FDA also states that the risks of combining microneedling devices with other products are not known.
When you compare quotes, the details to put side by side include who performs the treatment and with what license, the device used, the size of the area treated and the depth of the plan.
Two med spas can quote very different prices for what sound like the same session, so compare what is actually included.
A budget note for the whole category: IRS Publication 502, for 2025 returns, generally excludes cosmetic procedures — those directed at improving appearance that do not meaningfully promote body function or prevent or treat illness — from medical expense deductions, and by extension purely cosmetic skin treatments are generally not HSA or FSA eligible.
We would rather tell you there is no good national figure than repeat one. Local prices belong to local listings, and the honest questions are the plan price, the single-session price and the add-on price.
Find microneedling providers near you
Compare Google ratings, reviews and posted prices at med spas in your city.
What results can you expect, how many sessions, and how long do they last?
Microneedling runs on a slow clock.
The AAD says some improvement may be visible within a few weeks, but full results usually take several months, because the change comes as the body forms new collagen.
To see how results are documented, see microneedling before and after.
Plans are multi-session by design.
For acne scars, the AAD says a dermatologist may recommend 3 to 5 treatments performed every 2 to 4 weeks, and that studies have found this plan can fade acne scars by 50% to 70% — a research finding the AAD reports, not an outcome any one person is owed.
Cleveland Clinic describes the same kind of plan: multiple treatments spaced 3 to 8 weeks apart, with results that can take 3 to 6 months to appear.
The FDA's SkinPen pivotal study, though, shows more modest numbers than the AAD's summary.
In it, 41 adults with moderate-to-severe atrophic acne scars had three treatments scheduled about a month apart; 20 of them were treated with the final SkinPen device.
At 6 months after the last treatment, blinded assessors saw improvement in 55% of the SkinPen group (11 of 20) on photo grading; 45% showed no change, and none were graded worse.
A trial result is a group average, not a preview of your own outcome — and the study population included 11 of 41 subjects with Fitzpatrick skin type V or VI, with type I not studied.
For a closer look at the evidence, see does microneedling work.
SkinPen pivotal study: acne scars at 6 months
SkinPen group, blinded photo grading
Source: FDA De Novo DEN160029
And how long do results hold?
Neither the AAD nor Cleveland Clinic gives a fixed month count, so a page that quotes one is going beyond the sources.
The AAD says results fade as the body loses collagen, that sun protection and not smoking help preserve them, and that a dermatologist may recommend a yearly maintenance session.
Cleveland Clinic likewise notes a yearly maintenance treatment may be needed.
Does microneedling hurt, and what is the downtime?
Numbing comes first: Cleveland Clinic describes a numbing cream such as lidocaine applied 30 to 45 minutes before treatment.
During the treatment itself, Cleveland Clinic says you may feel warmth or a scratching sensation, and that discomfort is more likely where the needles pass over bone, such as the cheekbones.
Deeper treatment may cause a little bleeding.
Cleveland Clinic describes needle lengths of about 0.5 mm to 2 mm.
On downtime, the sources converge on "mild, not nothing." The AAD describes it as minimal: treated skin may look red on lighter skin or darker on darker skin tones and feel sunburned, with discomfort, burning or swelling that usually clears in a few days to a week.
The AAD says people can return to work or school immediately but should wait 24 hours before applying makeup.
Cleveland Clinic puts numbers on the same window: skin may stay red and swollen for up to five days, may burn or feel tight, and can become dry and flaky — the dryness improves with moisturizer.
It advises staying out of the sun until the skin heals.
For care after a session, see microneedling aftercare.
The recovery window, by source
| Milestone | Timing | Source |
|---|---|---|
| Numbing cream applied | 30 to 45 minutes before | Cleveland Clinic |
| Makeup | Wait 24 hours | AAD |
| Redness and swelling | Up to five days | Cleveland Clinic |
| Discomfort, burning or swelling | Usually clears in a few days to a week | AAD |
Cleveland Clinic advises contacting your provider if the treated area bleeds for longer than 24 hours, blisters, or stays swollen for longer than a week.
What are the side effects and risks?
The best numbers come from the SkinPen study itself.
The common responses there were temporary: redness, itching, peeling, discomfort or tenderness in 31% of subjects, lasting 1 to 3 days; dryness in 12%, lasting 1 to 6 days; burning in 9%; rough skin in 7%; and tightness in 4%.
No serious adverse events were recorded, and none of these responses persisted at the 6-month check.
Common treatment responses in the SkinPen study
Share of subjects; all temporary
Source: FDA De Novo DEN160029
The FDA's own risk list is broader.
Its common risks: dryness, rough skin, tightness, redness, itching, peeling, discomfort, burning, bruising, bleeding and crusting.
Its less common risks: pigment changes — skin turning darker or lighter — lines on the face, cold sore (herpes) reactivation, swollen lymph nodes, infection, and stinging or itching when cosmetics are applied to treated skin.
The FDA also notes that some side effects may be permanent, although most occur shortly after a treatment and resolve.
Two rarer items deserve mention.
Facial foreign-body granulomas — inflamed bumps that form when the body walls off material — were described in a 2014 JAMA Dermatology case series of 3 women after microneedling; two of the three had a vitamin C serum applied during treatment.
And for everything outside the authorized uses — off-label areas, combination treatments, devices the FDA has not evaluated — the FDA states plainly that the risks are not known.
CDC investigators traced five confirmed HIV infections to cosmetic injection services at an unlicensed New Mexico spa; four of the five people had received platelet-rich plasma "vampire facials" with microneedling there in 2018, and the fifth was a sexual partner. The inspection found unlabeled blood tubes stored with food and no autoclave. The FDA tells patients to ask whether a new needle cartridge is used for each patient and each session — re-use is unsafe even if the cartridge is cleaned.
Microneedling vs the alternatives: which is right for you?
The FDA's SkinPen decision summary starts from an honest place: no single acne-scar treatment works for everyone.
The alternatives it lists are laser treatment, punch excision, subcision, chemical peels, radiofrequency and temporary fillers, and it notes that lasers and peels may deliver more improvement but with higher risk and a longer recovery.
Depth is one way to see how the options differ.
Cleveland Clinic's comparison: microdermabrasion removes only the top layer of skin, chemical peels exfoliate deeper, and microneedling goes deeper still — which is why it may work better for problems beneath the surface, such as acne scars.
For microneedling versus chemical peels specifically, head-to-head evidence is close: a 2026 systematic review and meta-analysis of 11 studies and 713 participants found the two broadly comparable for atrophic acne scars, with no clear superiority for clinically significant improvement of 50% or more.
The variants change the tool, not the principle.
In radiofrequency (RF) microneedling, the needles deliver heat; the AAD says it may boost collagen and that some small studies suggest results similar to laser with less downtime, though more research in darker skin tones is needed.
The AAD's acne-scar guidance adds that radiofrequency combined with microneedling can produce less noticeable acne scars than either treatment alone, and that PRP used with microneedling can lead to less visible scarring.
On the two add-ons the FDA has addressed head-on, keep expectations calibrated.
The AAD describes PRP for skin rejuvenation as having little evidence behind it — an unproven treatment, with unanswered questions about the number of sessions, their spacing and the dosing; it notes that most patients who do see results have had 3 or more treatments.
Exosomes are earlier still: the FDA's December 2019 safety notification states that it has approved no exosome products, and it reported serious adverse events in Nebraska patients given unapproved exosome products.
Which option fits depends on the concern being treated, the type and depth of any scars, skin tone, budget and how much recovery time you can take.
Those are questions to work through with a licensed provider who examines your skin — not ones a price list or a treatment menu can answer.
Who should perform microneedling, and how do you find a med spa near you?
Who may perform microneedling near you is a question this page's research can answer for only one state: North Carolina, whose written rule we verified in detail.
Rules in other states were not verified for this page and may differ, so check with your state's board before you book.
North Carolina's rule: the state's Board of Cosmetic Art Examiners ruled, effective July 25, 2022, that licensed estheticians may perform microneedling with a device no deeper than 1 mm, while barring any product, device or technique that penetrates beyond the epidermis, the skin's outermost layer.
The same ruling reversed the board's 2020 position, which had put dermaplaning outside estheticians' scope.
Rules like these change, so treat North Carolina as an example, not a template for your state.
The AAD's advice is about training rather than job titles.
It says that when microneedling is performed by someone lacking medical training, the risk of infection, scarring or long-lasting skin discoloration rises, and it recommends a board-certified dermatologist.
Two other market segments come with the AAD's own warnings.
The AAD says at-home microneedling products and microneedling at a non-medical spa are not meant to puncture the skin and give less noticeable results; at-home use, it warns, risks overuse, infection, scarring and spreading warts or herpes.
If a "microneedling facial" is on a menu, it is fair to ask whether the treatment punctures the skin at all and who performs it.
When you search for microneedling near you, take the FDA's patient checklist along.
Ask whether the device is one the FDA has authorized, and whether a new needle cartridge is used for each patient and each session — the FDA calls re-use unsafe even if the cartridge is cleaned.
Ask who will perform the treatment, what license that person holds and under whose supervision, then verify the license with your state's board.
Get the plan in writing: how many sessions, how far apart, and what each visit and each add-on costs.
Frequently asked questions
Is microneedling FDA-approved?
No — and the word choice matters.
Microneedling devices are medical devices, so the accurate terms are authorized, cleared or granted, not approved.
The FDA has authorized specific microneedling devices, through the De Novo or 510(k) pathway, to improve the appearance of facial acne scars, facial wrinkles and abdominal scars in adults aged 22 or older.
The first was SkinPen Precision, granted in 2018 for facial acne scars.
Uses outside that list are off-label.
How many microneedling sessions do I need?
The sources describe series, not single visits.
For acne scars, the AAD says a dermatologist may recommend 3 to 5 treatments spaced 2 to 4 weeks apart.
Cleveland Clinic describes multiple treatments spaced 3 to 8 weeks apart, with results taking 3 to 6 months to appear.
In the SkinPen study, subjects had three treatments about a month apart.
Your plan depends on what is being treated, so ask a provider to put the session count and spacing in writing.
How long do microneedling results last?
No source on this page gives a fixed month count, so be careful with any figure you see quoted.
The AAD says results fade as the body loses collagen, that sun protection and not smoking help preserve them, and that a dermatologist may recommend a yearly maintenance session.
Some improvement can show within a few weeks, while full results usually take several months; Cleveland Clinic puts that at 3 to 6 months.
Can an esthetician perform microneedling?
This page's research verified only one state's written rule: North Carolina's.
Effective July 25, 2022, its Board of Cosmetic Art Examiners allows licensed estheticians to perform microneedling with a device no deeper than 1 mm, and bars anything that penetrates beyond the epidermis.
Rules in other states were not verified for this page and may differ, so ask any med spa who performs the treatment and check that license with your state's board.
What is PRP microneedling, and does it work?
PRP — platelet-rich plasma, drawn from your own blood — is the add-on behind the "vampire facial" name.
The evidence is thin: the AAD describes PRP for skin rejuvenation as having little evidence behind it, an unproven treatment with unanswered questions about the number of sessions, their spacing and the dosing.
The FDA also states that microneedling devices are not approved for delivering PRP into the skin, and that the risks of combining microneedling devices with other products are not known.
The AAD estimates cosmetic PRP sessions at $250 to $1,500 each.
Sources
Every number on this page comes from one of these sources and was checked against it.
- Microneedling Devices · U.S. Food and Drug Administration
- Device Classification Under Section 513(f)(2)(De Novo) · U.S. Food and Drug Administration
- accessdata.fda.gov · U.S. Food and Drug Administration
- Microneedling can fade scars, uneven skin tone, and more · American Academy of Dermatology
- Microneedling: What It Is, Uses, Benefits & Results · Cleveland Clinic
- Acne scars: Consultation and treatment · American Academy of Dermatology
- Microneedling Versus Chemical Peels for Atrophic Acne Scars: A Systematic Review and Meta-Analysis · National Library of Medicine
- Microneedling: A Review and Practical Guide · Alster et al., Dermatol Surg, 2018
- Facial allergic granulomatous reaction and systemic hypersensitivity associated with microneedle therapy for skin rejuvenation · Soltani-Arabshahi et al., JAMA Dermatol, 2014
- cdc.gov · CDC
- Is platelet-rich plasma the secret to younger-looking skin? · American Academy of Dermatology
- Public Safety Notification on Exosome Products · U.S. Food and Drug Administration
- nccosmeticarts.com · nccosmeticarts.com
- Is microdermabrasion right for you? · Cleveland Clinic
- Publication 502 (2025), Medical and Dental Expenses · irs.gov
- Vampire Facelift (Platelet-Rich Plasma Facelift) · Cleveland Clinic
Medical disclaimer. MedSpaStandard is for education only and is not medical advice. Talk to a licensed provider about your own health, and check any provider's license with your state board.