Part of the exosome treatments guide · 2 articles

Microneedling With Exosomes: Benefits, Cost and Results

Microneedling with exosomes is a microneedling session with an exosome-containing serum added to the treatment. The device part is FDA-authorized; the exosome part is not — FDA says there are currently no FDA-approved exosome products, and research on the combination is small and recent. Here is what the evidence shows, how the add-on is priced, and what to ask before you book.

None approvedFDA status of exosome productsFDA consumer alert; page content current as of 04/09/2024
18Human studies of topical exosomes2026 scoping review, from 2,394 articles screened
8 small studiesMicroneedling plus exosomes studies2026 systematic review; 3 to 60 participants each
Not verifiedExosome add-on priceno sourced national figure — ask how the practice prices it

Key takeaways

  • FDA says there are currently no FDA-approved exosome products.
  • Microneedling devices are FDA-authorized, but FDA says they are not approved for delivering cosmetics, drugs or other substances into the skin.
  • A 2026 systematic review of 8 small studies concluded more evidence is needed before the combination's safety and efficacy can be established.
  • No exosome add-on price was verified from any primary or professional source, so ask each practice how it prices the step.
  • Ask who performs the treatment, which device is used, and whether a new cartridge is used for each patient and each session.

What is exosome microneedling?

Exosome microneedling is not a separate device — it is a microneedling session with an exosome-containing topical product added, applied to the skin around the needling pass — the pitch is that the fresh micro-channels help it absorb.

The service picks up brand names, too: "SkinPen with exosomes" refers to SkinPen Precision, the first microneedling device the FDA authorized through its De Novo pathway, granted March 1, 2018.

Our exosome treatment guide covers the exosome products themselves.

The regulatory picture is the heart of this page.

On the device side, FDA has authorized non-RF microneedling devices to improve the appearance of facial acne scars, facial wrinkles and abdominal scars in patients aged 22 or older, and states that microneedling devices are not approved for delivering cosmetics, topical medications, vitamin solutions, drugs or blood products into the skin.

SkinPen's own authorization is narrower still: a prescription-use device to improve the appearance of facial acne scars in adults 22 or older, and not intended for transdermal delivery of cosmetics, drugs or biologics.

So "exosome microneedling" pairs an authorized device with an unapproved use — the combination is not on any current US label for either product.

On the product side, FDA's consumer alert (first posted July 22, 2020; content current as of 04/09/2024) states that there are currently no FDA-approved exosome products, and that exosome products intended to treat diseases or conditions in humans require FDA approval.

FDA also says clinics claiming their exosome products fall outside the rules for drugs and biological products are making a claim that is "simply untrue." Topical exosome-containing products are typically sold as cosmetics, a category that does not go through FDA premarket approval. "Approved," "cleared" or "registered" wording on a serum's marketing does not match the agency's public position, which is that no exosome product is approved.

The microneedling device

  • FDA-authorized to improve the appearance of facial acne scars, facial wrinkles and abdominal scars in patients aged 22 or older
  • Not approved for delivering cosmetics, topical medications, vitamin solutions, drugs or blood products into the skin

The exosome product

  • FDA says there are currently no FDA-approved exosome products
  • Exosome products intended to treat diseases or conditions in humans require FDA approval
  • Topical serums are typically sold as cosmetics, which do not go through FDA premarket approval
FDA's warning on exosome products

In December 2019, FDA issued a Public Safety Notification after multiple reports of serious adverse events in Nebraska patients treated with unapproved products marketed as containing exosomes. FDA also says the risks of off-label microneedling uses, and of combining microneedling devices with other products, are not known.

Claimed benefits vs the evidence

The combination has been studied for a specific set of goals: the 8 studies in a 2026 systematic review of microneedling plus exosomes covered skin aging, hyperpigmentation, scarring, enlarged pores and androgenetic alopecia (patterned hair loss).

That is the claimed-benefits list in research form.

Read those studies and two things stand out.

First, the base is thin: a 2026 Aesthetic Surgery Journal scoping review found only 18 human studies of topical exosomes for skin rejuvenation, from 2,394 articles screened, using both human- and plant-derived exosomes, and concluded human evidence is scarce.

Second, the products are hard to pin down — the same review found commercial products gave minimal information on exosome isolation, processing or shelf life.

That last point matters if you are comparing offers: two practices buying two different serums may not be using comparable products.

The combination-specific review is blunter.

Looking at 8 studies with 3 to 60 participants each, it concluded that more evidence is needed before the safety and efficacy of microneedling plus exosomes can be established.

A 2026 meta-analysis of 39 human exosome studies in aesthetics reported an average 20.2% reduction in facial wrinkles, but its authors note that heterogeneity and non-standardized protocols limit how far that average generalizes — and those 39 studies cover exosome treatments in aesthetics broadly, while the microneedling-specific pool is the smaller one above.

20.2%Average reduction in facial wrinkles across 39 human exosome studies in aesthetics2026 meta-analysis; authors note heterogeneity and non-standardized protocols limit how far it generalizes

Bottom line: we could not confirm any human study showing that adding exosomes makes microneedling results better or recovery faster than microneedling alone.

As for which exosome product is "best" for microneedling, our research found no independent comparison that ranks them, and the published review found the products themselves poorly documented.

The honest version of the pitch: early, small and thin on product detail — not the same as proof it works.

Cost compared with plain or PRP microneedling

The structure to understand is the add-on: a microneedling session price, then an exosome fee on top.

Practices may quote that fee per session or fold it into a package price, so ask which one you are getting — and whether the quote includes the base treatment or only the serum.

No dollar figure for the exosome add-on was verified from any primary or professional source when we researched this page, so we will not print one.

We found no verified national figure for a plain microneedling session either: the American Society of Plastic Surgeons' 2025 procedural statistics report we checked publishes no fee table, and RealSelf's microneedling cost page blocked access.

How plain microneedling itself is priced is covered in what microneedling costs.

One chain's published prices give a feel for the base treatment, not the add-on: LaserAway's price page (read October 16, 2026) listed SkinPen at $400 for the face ($300 each in a 6-pack) and Potenza RF microneedling at $750 ($562.50 in a 6-pack).

Those are LaserAway's own published prices, and they do not include an exosome step — any practice you are considering has its own add-on number.

The comparison add-on is PRP — the "vampire facial," where the serum is spun from your own blood — and it has an actual estimate, though an older one: the American Academy of Dermatology puts a PRP skin treatment session at $250 to $1,500 in the US, and notes insurance does not cover it because it is cosmetic.

That is an AAD estimate for PRP, not an exosome price, so the two are not like-for-like figures; no verified comparable exosome number exists to set beside it.

The PRP treatment itself is covered in PRP microneedling.

Published price points (not like-for-like)

TreatmentPriceSource
SkinPen, face$400 ($300 each in a 6-pack)LaserAway price page, read Oct 16, 2026
Potenza RF microneedling, face$750 ($562.50 in a 6-pack)LaserAway price page, read Oct 16, 2026
PRP skin treatment session$250 to $1,500AAD estimate
Exosome add-onNot verifiedNo primary or professional source

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Results and recovery

Recovery starts from the microneedling base, not the serum.

FDA lists common risks as dryness, rough skin, tightness, redness, itching, peeling, discomfort, burning, bruising, bleeding and crusting, with less common risks including pigment changes, lines on the face, cold-sore reactivation, swollen lymph nodes and infection.

Whether adding exosomes changes that profile is not established — the combination review's conclusion covered safety as well as efficacy.

Common microneedling risks (FDA)

  • Dryness, rough skin, tightness
  • Redness, itching, peeling
  • Discomfort, burning
  • Bruising, bleeding, crusting

Less common risks (FDA)

  • Pigment changes
  • Lines on the face
  • Cold-sore reactivation
  • Swollen lymph nodes
  • Infection

The same honesty applies to results.

There is no verified exosome-specific timeline — no confirmed session count, no confirmed month count — and a pooled figure like the 20.2% average above comes from mixed studies, so it is not a prediction for any one person.

Treat any promised before-and-after with that in mind: photos show someone else's result, never yours.

The device under the serum matters as well.

If a practice pairs the exosome step with a radiofrequency (RF) microneedling device rather than a standard microneedling device — a detail to confirm when you book — the RF device brings its own FDA-flagged risks, covered below.

FDA's suitability list is written for microneedling devices: FDA says microneedling may not be suitable for people who are pregnant or breastfeeding, take isotretinoin now or took it in the past 6 months, have bleeding disorders or take blood thinners, are immunosuppressed, have an active skin infection or cold-sore outbreak, have a keloid history or uncontrolled diabetes, or are tan — and it flags a risk of the skin darkening or lightening in darker skin types.

FDA's 2025 warning on RF microneedling

On October 15, 2025, FDA reported serious complications with RF microneedling used for aesthetic skin procedures — burns, scarring, fat loss, disfigurement and nerve damage, sometimes needing surgical repair. FDA says RF microneedling is a medical procedure, not a cosmetic treatment, and the devices should not be used at home.

Find exosome microneedling near you

Who may perform a treatment like this, and under what supervision, is set by rules that vary by state.

AmSpa, the med spa trade association, describes the pattern using botulinum toxin injections as its example: because a prescription drug affects living tissue, the injection falls under the practice of medicine and must be done by a physician, an independent-practice nurse practitioner or another licensed professional acting within their scope.

Where an exosome serum sits in that framework in your state is a question to put to the practice directly.

Five questions to ask before you book:

  • Who performs the treatment, and what license do they hold?
  • Which microneedling device will be used, and is a new cartridge used for each patient and each session? FDA says re-using a cartridge, even if cleaned, is unsafe.
  • Has the FDA reviewed the exosome product? FDA's advice is to ask whether the treatment has been reviewed and to ask for the FDA Investigational New Drug (IND) number; it notes legitimate trials require signed informed consent overseen by an Institutional Review Board.
  • Can the practice explain how the serum's exosomes are isolated and processed, and what the shelf life is? The 2026 scoping review found commercial products gave minimal information on all three.
  • How is the exosome step priced — per session or bundled — and what exactly does the quote include?

Those answers are the local data this page cannot supply: we found no verified national price for the add-on, and the published review found the products themselves poorly documented.

If a practice points to FDA approval, clearance or "registration" for an exosome serum as proof of safety, that does not match the agency's public position that no exosome product is approved.

And whether the add-on makes sense for your skin is a judgment to make with a licensed provider who has actually examined it.

Frequently asked questions

Are exosomes FDA-approved?

No. FDA's consumer alert states there are currently no FDA-approved exosome products, and that exosome products intended to treat diseases or conditions in humans require FDA approval.

FDA also says clinics claiming their exosome products fall outside the rules for drugs and biological products are making a claim that is "simply untrue." Topical exosome serums are typically sold as cosmetics, a category that does not go through FDA premarket approval.

Is microneedling with exosomes worth it?

The evidence does not settle it.

The systematic review of the combination covered 8 studies with 3 to 60 participants each and concluded more evidence is needed before its safety and efficacy can be established.

A broader 2026 meta-analysis of 39 human exosome studies in aesthetics reported an average 20.2% reduction in facial wrinkles, while noting the studies' protocols were not standardized.

Whether the add-on justifies its price is a question to work through with a licensed provider.

How much does microneedling with exosomes cost?

It is an add-on to the microneedling session price: practices may quote the exosome fee per session or fold it into a package, so ask which.

No add-on price was verified from any primary or professional source when we researched this page, so there is no national figure to quote.

For scale on the base treatment, LaserAway's published price page listed SkinPen at $400 for the face when checked in October 2026, and an older American Academy of Dermatology estimate puts PRP skin treatment sessions at $250 to $1,500.

Ask each practice for its own add-on price.

What are the risks of microneedling with exosomes?

From the microneedling base, FDA lists common risks: dryness, rough skin, tightness, redness, itching, peeling, discomfort, burning, bruising, bleeding and crusting; less common are pigment changes, lines on the face, cold-sore reactivation, swollen lymph nodes and infection.

For the combination specifically, the 2026 systematic review concluded more evidence is needed before its safety and efficacy can be established.

FDA also states there are no approved exosome products, and its 2019 safety notification followed serious adverse events with unapproved exosome products in Nebraska.

Sources

Every number on this page comes from one of these sources and was checked against it.

  1. Device Classification Under Section 513(f)(2)(De Novo) · U.S. Food and Drug Administration
  2. accessdata.fda.gov · U.S. Food and Drug Administration
  3. Potential Risks with Certain Uses of Radiofrequency Microneedling · U.S. Food and Drug Administration
  4. Microneedling Devices · U.S. Food and Drug Administration
  5. Vampire Facelift (Platelet-Rich Plasma Facelift) · Cleveland Clinic
  6. Is platelet-rich plasma the secret to younger-looking skin? · American Academy of Dermatology
  7. Consumer Alert on Regenerative Medicine Products Including Stem Cells · U.S. Food and Drug Administration
  8. Public Safety Notification on Exosome Products · U.S. Food and Drug Administration
  9. Clinical Evidence and Commercial Landscape of Topical Exosomes for Skin Rejuvenation: A Scoping Review · Knauer et al., Aesthet Surg J, 2026
  10. The Use of Microneedling With Exosomes in Dermatology: A Systematic Review · Dhaliwal et al., J Cosmet Dermatol, 2026
  11. Clinical Advances in Exosome-Based Therapies for Aesthetic Medicine: A Systematic Review and Meta-analysis of Human Clinical Trials · Stack et al., Aesthet Surg J, 2026
  12. LaserAway Treatment Prices · laseraway.com
  13. What Are the Rules for Who Can Inject Neurotoxins? · American Med Spa Association

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.