Skin & facials

Exosome Treatments: Exosome Facials and Microneedling at Med Spas

Exosome treatments are procedures marketed as delivering exosomes to the skin — topical serums applied around a treatment such as microneedling. There are currently no FDA-approved exosome products, and the human evidence is early: a 2026 review found 18 human studies of topical exosomes for skin rejuvenation. Here is what the treatments involve, what the FDA says about them, and what the research does and does not show.

No approved productsFDA statusFDA: currently no FDA-approved exosome products (alert current as of 04/09/2024)
18Human studies of topical exosomes2026 scoping review, skin rejuvenation
20.2%Average wrinkle reduction in studies2026 meta-analysis of 39 human exosome studies in aesthetics — not a prediction for any one person
Not verifiedTypical priceno sourced national add-on price — ask practices

Everything in the exosome treatments guide

2 articles · each one checked against its sources
  1. Microneedling With Exosomes: Benefits, Cost and Results8 min
  2. Exosome Injections: Are They Legal and Safe?6 min

Key takeaways

  • FDA states there are currently no FDA-approved exosome products.
  • FDA says microneedling devices are not approved for delivering cosmetics, drugs or other substances into the skin, so exosome microneedling pairs an authorized device with an unapproved use.
  • Human evidence is early: 18 human studies of topical exosomes, and 8 small studies of the microneedling combination.
  • No add-on price was verified from any primary or professional source. Ask each practice what it charges.
  • Ask whether FDA has reviewed the product, and whether a new microneedle cartridge is used for each patient and each session.

What is exosome treatment and how does it work?

An exosome treatment at a med spa is a category, not one branded procedure.

The products are topicals marketed as containing exosomes — particles that the studies in a 2026 scoping review in Aesthetic Surgery Journal derived from human cells or plants.

They are applied to the skin, and in the published studies they have been paired with a delivery device such as microneedling.

Topical exosome products are typically sold as cosmetics, and cosmetics do not go through FDA premarket approval.

That last point frames everything else on this page: FDA states there are currently no FDA-approved exosome products.

The agency's consumer alert on regenerative medicine products, which includes stem cells and exosomes, was dated July 22, 2020, with content current as of 04/09/2024.

FDA's position is that exosome products intended to treat diseases or conditions in humans are regulated as drugs and biological products and require premarket review and approval — and it calls clinics' claims that exosomes fall outside those rules 'simply untrue'.

For exosomes given by injection rather than applied to the skin, see exosome injections.

How the treatment is supposed to work is the part marketing fills in and the research does not.

The scoping review concluded that human evidence is scarce and that commercial products gave minimal information on exosome isolation, processing or shelf life.

When exosomes are paired with microneedling, the device itself is familiar territory — but FDA says microneedling devices are not approved for delivering cosmetics, drugs or other substances into the skin, so the combination pairs an authorized device with an unapproved use.

Where exosome products sit with FDA

FDA regulates exosome products intended to treat diseases or conditions as drugs and biological products, which require premarket review and approval — and FDA states there are currently no FDA-approved exosome products. Topical exosome products are typically sold as cosmetics, which do not go through FDA premarket approval.

What does exosome treatment treat, and who is a good candidate (and who isn't)?

Start with what the studies looked at, because that is narrower than what some marketing implies.

The 2026 systematic review of microneedling plus exosomes found 8 studies, with 3 to 60 participants each, covering skin aging, hyperpigmentation, scarring, enlarged pores and androgenetic alopecia (pattern hair loss).

The same review concluded that more evidence is needed before the safety and efficacy of the combination can be established.

Studied is not the same as proven.

8Studies of microneedling plus exosomes2026 systematic review
3–60Participants per study2026 systematic review

An established candidate profile for exosome treatments?

We found no published candidacy criteria for cosmetic exosome products in the sources we reviewed, and no FDA-approved product to attach one to.

What is established concerns the procedure the serum rides on.

FDA says microneedling may not be suitable for people who are pregnant or breastfeeding, take isotretinoin now or 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.

FDA also flags a risk of pigment change in darker skin types.

The other 'who isn't' is regulatory.

If a practice presents exosomes as treating a disease or medical condition, that is the territory FDA says requires an approved drug or biologic — and there are none.

For your own case, the person to ask is a licensed provider who can examine your skin and its history.

How much does exosome treatment cost at a med spa?

Exosome products are priced as add-ons to a base treatment, so the number to ask about is the add-on fee on top of the procedure itself.

No price for that add-on was verified from any primary or professional source when we researched this page, so this page gives no dollar figure — and any specific amount you see quoted online is worth treating with caution.

What you would pay depends on the base procedure it is paired with, the specific exosome product used and the practice's own pricing.

Practices may quote the add-on per session or fold it into a package price.

Ask any practice you are considering what the exosome add-on costs, whether it is charged per session or bundled, and whether the quote includes the base treatment or only the serum.

Find exosome treatment 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?

The most specific number in the literature comes with heavy caveats.

A 2026 meta-analysis of 39 human exosome studies in aesthetics reported an average 20.2% reduction in facial wrinkles (95% CI, 15.3% to 25.2%).

The authors note that heterogeneity and non-standardized protocols across studies limit how far that average can be generalized, and a study average is not a prediction for any one person.

Other reviews describe a young evidence base.

A separate 2026 scoping review found only 18 human studies of topical exosomes for skin rejuvenation, from 2,394 articles screened.

For the combination this page is about — microneedling plus exosomes — a third 2026 review found 8 studies, with 3 to 60 participants each, and concluded more evidence is needed before the safety and efficacy of the combination can be established.

2,394Articles screened to find 18 human studies of topical exosomes for skin rejuvenation2026 scoping review, Aesthetic Surgery Journal

On sessions and duration we will be blunt: we could not confirm how many exosome sessions are typical or how long results last, and no source we reviewed establishes either.

For the microneedling portion, FDA notes that more than one session may be needed.

Ask any practice quoting you a session count or a duration where its numbers come from.

Does exosome treatment hurt, and what is the downtime?

No published data we reviewed measures pain from the exosome serum itself.

The published risk lists we can cite are for the procedure it is usually paired with: FDA lists discomfort, burning, bruising and bleeding among the common risks of microneedling devices, alongside dryness, tightness, redness, itching, peeling and crusting.

On recovery, the American Academy of Dermatology says microneedling downtime is minimal: redness — or darker shades on darker skin — a sunburn-like feeling, burning or swelling usually clear within a few days to a week, people can return to work immediately, and makeup should wait 24 hours.

That describes microneedling alone.

It is not a description of microneedling plus an unapproved serum, where FDA says the risks of combining devices with other products are not known.

Microneedling alone (AAD)

  • Redness, a sunburn-like feeling, burning or swelling usually clear within a few days to a week
  • Return to work immediately
  • Wait 24 hours before makeup

Microneedling plus an exosome serum

  • No published data we reviewed measures pain from the serum itself
  • FDA says the risks of combining microneedling devices with other products are not known

What are the side effects and risks?

The honest answer has three layers: the product, the combination and the procedure.

The product layer is the one FDA has warned about.

On December 6, 2019, FDA issued a Public Safety Notification on exosome products after multiple serious adverse events in Nebraska patients treated with unapproved products marketed as containing exosomes.

The notification does not describe how those products were given or the clinical details behind the events.

What it left in place is the agency's standing position: no exosome products are approved, and claims that they fall outside drug and biologic rules are, in FDA's words, 'simply untrue'.

The combination layer has the thinnest evidence.

FDA says the risks associated with off-label uses of microneedling devices — and with combining microneedling devices with other products — are not known.

The 2026 review of microneedling plus exosomes reached the same conclusion from the evidence side: more evidence is needed before the safety and efficacy of the combination can be established.

Product quality is part of this.

The scoping review found commercial products gave minimal information on exosome isolation, processing or shelf life.

The procedure layer is the familiar one.

FDA lists microneedling's common risks as dryness, rough skin, tightness, redness, itching, peeling, discomfort, burning, bruising, bleeding and crusting, with less common risks including pigment changes, cold-sore reactivation and infection.

If you have a reaction that concerns you after any treatment, contact the practice that performed it and seek medical care.

Three layers of risk

LayerWhat the sources say
The productFDA Public Safety Notification on December 6, 2019 after serious adverse events in Nebraska patients; no approved exosome products
The combinationFDA: risks of combining microneedling devices with other products are not known; 2026 review: more evidence is needed
The procedureFDA: common microneedling risks include dryness, redness, peeling, burning, bruising, bleeding and crusting
FDA's warning on exosome products

There are currently no FDA-approved exosome products. In December 2019, FDA issued a Public Safety Notification after multiple serious adverse events in Nebraska patients treated with unapproved products marketed as containing exosomes — and it calls clinics' claims that exosome products fall outside drug and biologic rules 'simply untrue'.

Exosome treatment vs the alternatives: which is right for you?

The treatments exosomes are sold alongside are better mapped, though none is a mirror image.

Microneedling alone is the baseline.

FDA has authorized microneedling devices to improve the appearance of facial acne scars, facial wrinkles and abdominal scars in patients aged 22 or older — the device indication covers the microneedling itself, not delivering cosmetics, drugs or other substances into the skin.

The American Academy of Dermatology calls microneedling a medical treatment that uses tiny needles to puncture the skin and stimulate collagen ('collagen induction therapy'), used for acne scars, dark spots, large pores, melasma, stretch marks, texture and fine lines.

PRP microneedling — the 'vampire facial' — draws your own blood, spins it in a centrifuge to separate platelet-rich plasma, spreads it over the face and uses microneedling to help it absorb.

AAD calls PRP skin rejuvenation 'still an unproven treatment' and says dermatologists do not yet know the best number of sessions, spacing, dose or equipment.

Like exosomes, PRP is not something microneedling devices are approved to deliver.

Evidence and FDA status at a glance

OptionFDA statusEvidence
Microneedling aloneDevices authorized for facial acne scars, facial wrinkles and abdominal scars (ages 22+)AAD: a medical treatment that stimulates collagen
PRP microneedlingMicroneedling devices are not approved to deliver PRPAAD: 'still an unproven treatment'
ExosomesNo FDA-approved exosome products18 human studies of topical exosomes; 8 small studies of the microneedling combination

Exosomes sit a step earlier in the evidence: 18 human studies of topical exosomes, 8 small studies of the microneedling combination, no approved products, and minimal published information on exosome isolation, processing or shelf life.

Which one to ask about is not a decision this page can make — it depends on your skin, your goals and what a licensed provider finds on examination.

What the comparison does give you is the level of evidence behind each option.

Who should perform exosome treatment, and how do you find a med spa near you?

We found no federal rule naming who may apply a cosmetic serum, and no state rule written for exosome products specifically.

What exists is the structure around the procedure.

FDA notes that microneedling may count as a medical procedure, not a cosmetic one, when the device is intended to change the structure or function of tissue.

AmSpa, the med spa trade association, describes the pattern using botulinum toxin as its example: because a prescription drug is being used to affect living tissue, the injection falls under the practice of medicine and must be done by a physician, an independent-practice NP or another licensed professional acting within their scope, under rules that vary by state.

Whether a given exosome service falls under that umbrella in your state is a question for the practice and your state's rules.

The questions worth asking before you book:

  • Who performs the treatment, and what license do they hold?
  • Has the FDA reviewed the exosome product? FDA's own advice is to ask whether the treatment has been reviewed by FDA and to ask for the FDA-issued Investigational New Drug (IND) number; legitimate trials require signed informed consent overseen by an Institutional Review Board.
  • Is a new, sterile microneedle cartridge used for each patient and each session? FDA says re-using a cartridge, even if cleaned, is unsafe.
  • What does the practice know about how the product's exosomes are isolated and processed, and what its shelf life is? The scoping review found commercial products gave minimal information on all three.

A claim that an exosome serum carries FDA approval or clearance, or an FDA 'registration' as proof of safety, does not match the agency's public position.

Who may perform a given service, and under what supervision, is decided under rules that vary by state — the questions above travel with you anywhere.

Frequently asked questions

Are exosomes FDA-approved?

No. FDA states there are currently no FDA-approved exosome products, in a consumer alert dated July 22, 2020, with content current as of 04/09/2024.

The agency's position is that exosome products intended to treat diseases or conditions are regulated as drugs and biological products that require premarket approval.

Topical exosome products are typically sold as cosmetics, which do not go through FDA premarket approval.

What is an exosome facial?

A marketing name for an exosome-containing topical applied around a skin procedure such as microneedling — the pairing described in the published studies.

FDA says microneedling devices are not approved for delivering cosmetics, drugs or other substances into the skin, so the combination pairs an authorized device with an unapproved use.

A 2026 systematic review found 8 small studies of microneedling plus exosomes, and the review's authors concluded more evidence is needed.

Do exosomes really work for skin?

The evidence is early and limited.

A 2026 meta-analysis of 39 human exosome studies in aesthetics reported an average 20.2% reduction in facial wrinkles, with the authors cautioning that heterogeneity and non-standardized protocols limit how far the average generalizes.

A scoping review found just 18 human studies of topical exosomes, and a review of microneedling plus exosomes concluded more evidence is needed.

How much do exosomes cost at a med spa?

We could not verify a price for exosome add-ons from any primary or professional source, so we will not quote one.

Exosomes are sold as add-ons to a base treatment such as microneedling, and the add-on fee is set practice by practice.

Ask any practice you are considering what the exosome add-on costs, whether it is charged per session, and whether it is bundled with the base treatment.

Are exosome treatments safe?

Safety is not established.

FDA says the risks of combining microneedling devices with other products are not known.

A 2026 review of 8 small studies of microneedling plus exosomes concluded more evidence is needed before the safety and efficacy of the combination can be established.

FDA issued a Public Safety Notification in December 2019 after serious adverse events with unapproved exosome products in Nebraska, and no exosome product exists that FDA has approved.

Sources

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

  1. Microneedling Devices · U.S. Food and Drug Administration
  2. Is platelet-rich plasma the secret to younger-looking skin? · American Academy of Dermatology
  3. Vampire Facelift (Platelet-Rich Plasma Facelift) · Cleveland Clinic
  4. Consumer Alert on Regenerative Medicine Products Including Stem Cells · U.S. Food and Drug Administration
  5. Public Safety Notification on Exosome Products · U.S. Food and Drug Administration
  6. Clinical Evidence and Commercial Landscape of Topical Exosomes for Skin Rejuvenation: A Scoping Review · Knauer et al., Aesthet Surg J, 2026
  7. The Use of Microneedling With Exosomes in Dermatology: A Systematic Review · Dhaliwal et al., J Cosmet Dermatol, 2026
  8. 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
  9. Microneedling can fade scars, uneven skin tone, and more · American Academy of Dermatology
  10. What Are the Rules for Who Can Inject Neurotoxins? · American Med Spa Association
  11. Exosomes and Hair Regeneration: A Systematic Review of Clinical Evidence Across Alopecia Types and Exosome Sources · Al et al., Clin Cosmet Investig Dermatol, 2025

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.