The FDA has reviewed and legally authorized specific microneedling products as medical devices for use in specific areas of the body.
On this page:
- What are Microneedling Devices?
- Legally Marketed Uses of Microneedling Devices
- Risks of Using Microneedling Devices
- Information for Patients About Microneedling Devices
- Information for Health Care Providers About Microneedling Devices
What Are Microneedling Devices?
Microneedling devices are instruments with technological features, such as many small needles, tips, or pins on the surface, which are repeatedly inserted and removed into the skin. For example, the needles may be attached to a cylinder that is rolled across the skin, project from a flat surface that is "stamped" on the skin, or arranged in a pattern on the tip of a pen-shaped instrument.
Microneedling devices create many small puncture holes in the skin by moving over the skin repeatedly. Some microneedling devices are manual, meaning the needles always project from the surface, and they enter the skin when the device is rolled or stamped on the surface. Other devices use a motor to move needles in and out of the device surface. In some motorized devices, the health care practitioner can adjust and control the depth and speed of penetration of needles into the skin.
Legally Marketed Uses of Microneedling Devices
The FDA 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. This means the FDA has reviewed data to support a reasonable assurance of the safety and effectiveness of these devices for these uses.
- Summary documents for De Novos which have been granted or 510(k)s which have been cleared are publicly available on FDA's website. To view these De Novo Decision Summaries or 510(k) Summaries, please check the following databases:
- De Novo database and search for specific devices or De Novos in the General and Plastic Surgery Panel
- 510(k) database and search for specific devices or the product code, QAI
- To date, the FDA has only granted marketing authorization for a limited number of medical devices for specific uses in specified areas of the face and body. The FDA may not have reviewed the use of certain microneedling devices for all locations in the body. The public summary links above specify the intended areas of the face and body for each legally-marketed microneedling device.
Some microneedling products may not be medical devices. For example, generally, microneedling products that do not penetrate into the living skin layers (epidermis and dermis) and claim only to do the following would not be devices:
- Facilitate exfoliation of the skin (that is, disruption or removal of the stratum corneum)
- Improve the appearance of skin
- Give skin a smoother look and feel
- Give skin a luminous look
For additional information regarding whether a microneedling product meets the definition of a medical device and how microneedling devices are regulated, see the FDA's guidance Regulatory Considerations for Microneedling Products.
Risks of Using Microneedling Devices
As with any medical procedure, there are risks involved with the use of microneedling devices. That is why it is important for you to understand their limits and possible risks.
Any microneedling device has the potential to cause side effects that last a short time or a long time. Some side effects may be permanent. However, most side effects associated with microneedling occur shortly after a treatment and resolve. Microneedling procedures may not always result in the desired aesthetic outcome.
The following risks are associated with FDA-authorized uses of microneedling devices.
Common risks include:
- Rough skin
Less common risks include:
- Pigmentation changes (increase in pigment (hyperpigmentation) or loss of pigment (hypopigmentation)
- Lines on the face
- Reactivation of herpes cold sores
- Swollen lymph nodes
- Stinging or itching when cosmetic products are applied
The risks associated with other uses ("off label uses") of microneedling devices, the combination of microneedling devices with other products, or the use of microneedling products that have not been evaluated by the FDA are not known.
Information for Patients About Microneedling Devices
If you are considering a microneedling procedure, the FDA recommends that you:
- Talk to your health care provider regarding the anticipated benefits and risks associated with treatment.
- Select a health care provider who is trained to perform microneedling procedures. Ask your health care provider about his or her training and experience with microneedling.
- Be aware that microneedling may be considered a medical procedure, not a cosmetic procedure, when it meets the definition of a medical device, for example, if intended to change the structure or function of tissue. There are also risks, which are listed above. 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.
- Be aware that you may need more than one procedure to get the desired aesthetic improvement.
- Ask your health care provider how the device is cleaned between patients.
- Ask your health care provider whether a new microneedle cartridge is used for each patient, and for each treatment session for the same patient. Re-use of the needle cartridge is unsafe and is not consistent with the FDA's review and authorization, even if the cartridge is cleaned.
- Ask for patient labeling which is available with FDA-authorized microneedling devices.
The procedure may NOT be suitable for you if you:
- Have a known history of clotting or bleeding disorders such as hemophilia.
- Are immune deficient or immune suppressed due to medical conditions or medications.
- Suffer from uncontrolled diabetes (high blood sugar).
- Take anticoagulant (blood thinner) therapies such as warfarin,heparin, or low dose aspirin.
- Suffer from an active skin infection, including bacterial, viral, or fungal infection.
- Suffer from an infection such as hepatitis or human immunodeficiency virus (HIV).
- Have or had eczema, psoriasis, vitiligo, or auto-immune disease.
- Have an active rash on the face.
- Have a current outbreak of cold sores (herpes).
- Are currently taking acne medication with the ingredient isotretinoin (Accutane) or have taken isotretinoin in the past 6 months.
- Have actinic (solar) keratoses, keloid scars (or a history of keloid scars), warts, , or birthmarks or moles in the treatment area.
- Have darker skin type, as there is a risk of darkening or lightening of the skin after the procedure. Some of the devices authorized for marketing by the FDA were not studied in subjects with darker skin types.
- Are tan or planning to be in the sun in the two weeks following the procedure.
- Suffer from a known malignancy or are undergoing or about to undergo treatments using chemotherapy, radiotherapy, or steroids.
- Are pregnant or breastfeeding.
- Are allergic to stainless steel or to topical or local anesthetics or have a history of contact dermatitis to these products.
Information for Health Care Providers About Microneedling Devices
- Use only FDA-authorized microneedling devices. The FDA urges health care providers to inspect all microneedling packages for authenticity and check if the microneedling device that you have purchased is listed in the FDA's De Novo database or 510(k) Premarket Notification database.
- The FDA is aware of several microneedling devices that are not legally marketed. The safety and effectiveness of these devices has not been reviewed by the FDA.
- Do not use microneedling devices if you do not have the appropriate training or experience.
- Follow all instructions regarding the cleaning and disinfection of microneedling devices.
- Do not reuse a microneedling cartridge or use a microneedling cartridge on more than one patient as this could cause transfer of infectious agents.
- Consider use of prophylactic antivirals in patients with a history of herpes simplex.
- Know the signs and symptoms of complications associated with microneedling devices and have an updated plan detailing how the patient will be treated should this occur. This may include on-site treatment and/or immediate referral to another health care provider for treatment.
- Tell patients that they should seek immediate medical attention if they experience signs or symptoms of complications associated with microneedling devices.
- Educate facility staff and employees on how to assist patients calling with signs and symptoms of complications related to microneedling devices and on how to receive appropriate medical care.
- Report to the FDA and the manufacturer if you become aware of any serious adverse event associated with the use of microneedling devices, including infection, cross-contamination, and device malfunctions.
- Consider that there are many alternative treatments to a microneedling device, including lasers, other energy-based devices, chemical peels, and dermal fillers. Discuss the benefits and risks of each treatment option with patients.