The FDA safety notice on RF microneedling
The FDA’s RF microneedling safety communication, explained
On 15 October 2025 the FDA warned that serious complications, including burns, scarring, fat loss, disfigurement and nerve damage, have been reported with RF microneedling used for cosmetic skin procedures, and that some needed surgical repair or other treatment. The notice names no brand and orders no recall. It asks patients to choose a licensed, trained provider, to ask which device will be used, and to report problems. Potenza is one of the devices in this category.
Written by the Potenza Seoul editorial team and medically reviewed by a Korean Board-Certified Dermatologist (AAD International Fellow · ASLMS member). Last reviewed: .
What exactly did the FDA say?
The FDA’s safety communication “Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling” was issued on 15 October 2025 (FDA, checked 18 October 2026). It covers RF microneedling used “to treat wrinkles or to achieve skin effects, sometimes referred to as resurfacing, ‘tightening’ or ‘rejuvenation’”. For those uses, the FDA says it is aware of reports of serious complications “including burns, scarring, fat loss, disfigurement, and nerve damage, and the need for surgical repair or medical intervention to treat injuries”.
Its advice to patients and caregivers comes down to six points:
- Be aware of the serious complications that have been reported.
- Discuss the benefits and risks of all available skin procedures with your provider.
- Choose a licensed provider with training and experience in RF microneedling, and ask which devices they plan to use.
- Remember that “RF microneedling is a medical procedure, not a cosmetic treatment, and these devices should not be used at home.”
- See a licensed provider if you have problems or concerns after treatment.
- Report problems or complications to the FDA.
The FDA says its evaluation is ongoing, that it is working with manufacturers to identify ways to reduce the risk, and that it will update the public if significant new information emerges. When we checked on 18 October 2026, the page was still marked as current as of 15 October 2025.
What does the notice leave open?
The notice is a signal, not a rate. It names no device or manufacturer, gives no count of reports and announces no recall. A search of the FDA medical device recall database on 18 October 2026 returned no records for Potenza (FDA recall database).
Nor does the notice call RF microneedling unsafe as a whole. Its message is narrower and practical: serious injuries have been reported, the procedure belongs in trained medical hands, and patients should know exactly which device is being used on them.
What do FDA complaint reports show?
Two 2026 studies counted reports in MAUDE, the FDA database where manufacturers, facilities and patients log suspected device problems.
A team at Massachusetts General Hospital found 114 reports describing 224 events from January 2013 to October 2025. Of those reported events, the most frequent were texture changes (25.0%), pigment changes (18.3%) and fat loss (11.6%), followed by inflammatory reactions (8.0%), burns (6.3%) and pain (5.4%). The face, neck and abdomen were the most treated areas.[1]
A second analysis of 2020 to 2025 found 86 reports with 145 adverse events. Fat loss, scarring and post-inflammatory redness were reported most often. The authors pointed to settings adjusted for the patient and the indication, and to real-time device feedback, as ways to improve safety.[2]
These figures describe what was reported, not how often problems happen: nobody knows how many treatments were performed in the same years, and reporting is voluntary for patients. Outside complaint data, a review of 35 studies in skin types III to VI found a low risk of scarring or hyperpigmentation with RF and RF microneedling.[3]
Why do depth and energy settings matter so much?
In the FDA’s own description, each microneedle “produces a small area of intense heat at its tip”, and the needles let RF energy “reach specific depths within and under the skin”. Depth and energy are therefore not cosmetic details: they decide which tissue is heated. Potenza’s needles can be set anywhere from 0.5 to 4.0 mm, so the same device can treat a shallow texture problem or reach far deeper. See how Potenza works for the modes and tips.
What does Potenza’s FDA record say?
The FDA notes that RF microneedling devices are Class II devices cleared through the 510(k) process. Potenza and its newer model, Potenza Prime, have five 510(k) clearances between them, from February 2020 to September 2026. Each lists the same use, “dermatologic and general surgical procedures for electrocoagulation and hemostasis”, for prescription use only.
| 510(k) | Decision date | What it added |
|---|---|---|
| K192545 | 20 February 2020 | The system: monopolar and bipolar modes at 1 or 2 MHz |
| K201685 | 19 January 2021 | Four more needle tips, including CP-21 |
| K231287 | 5 November 2024 | A handpiece with non-invasive DDR, SFA and Diamond tips |
| K231216 | 10 December 2024 | Three more CP-series tips: CP-16, CP-25 and CP-49 |
| K254185 | 11 September 2026 | Potenza Prime, a 1 MHz model; DDR tips above 62 mJ/pin limited to skin types I–IV |
Records: K192545, K201685, K231287, K231216 and K254185. In plain terms, the FDA cleared Potenza as an electrosurgical device for coagulating tissue. Uses such as acne scars or pores rest on published studies and medical judgement, not on the cleared wording. Separately, the FDA states that microneedling devices are not approved to deliver drugs or blood products such as PRP into the skin (FDA microneedling devices page, checked 18 October 2026).
In Korea, the maker describes Potenza as a medical device approved by the Ministry of Food and Drug Safety (Jeisys, checked 18 October 2026).
What should you ask a clinic before RF microneedling?
Which device and tip will you use?
Why it matters. The FDA specifically advises asking which device a provider plans to use, and tips differ in depth and insulation.
What a good answer includes. A named device and tip, with the reason it suits your concern.
Treat with caution. A house name for the device, or “the same as Potenza”, with no brand you can look up.
Who will perform the treatment and set the parameters?
Why it matters. The FDA recommends a licensed provider with training and experience in RF microneedling.
What a good answer includes. A doctor who examines you and chooses or supervises the settings.
Treat with caution. Settings chosen from a menu without a skin examination.
How deep will you go over my jaw, neck and thin areas?
Why it matters. Fat loss is among the complications reported most often to the FDA.
What a good answer includes. Depths that vary by area, with a reason for each.
Treat with caution. One depth and energy for the whole face.
Is a new sterile tip opened for me?
Why it matters. Potenza tips are single-use sterile products, and the FDA calls re-use of microneedle cartridges unsafe even after cleaning.
What a good answer includes. The tip package is opened in front of you.
Treat with caution. No clear confirmation that the tip is new and single-use.
Will any product be applied to the treated skin?
Why it matters. The FDA states that microneedling devices are not approved to deliver drugs or blood products, and that the risks of combinations are not known.
What a good answer includes. The product is named, and you can decline it.
Treat with caution. An unnamed booster included by default.
What happens if I have a problem after I fly home?
Why it matters. Burns and infections need prompt care, and follow-up is harder from abroad.
What a good answer includes. Written aftercare, a direct contact, and an offer to review photos.
Treat with caution. No contact once you leave the clinic.
How do you report a problem?
In the United States, patients and providers can report through the FDA’s MedWatch voluntary reporting form, which is linked from the safety notice. If you were treated in Seoul, contact the treating clinic first and keep the device name, tip type, treatment date and photos; those details make any report useful.
Did the FDA ban RF microneedling?
No. The notice warns about reported complications and gives advice. It does not ban, recall or name a device.
Does the FDA warning cover Potenza?
The notice covers RF microneedling devices as a group and names none. Potenza is an RF microneedling device cleared through the 510(k) route, so the advice applies to it as it does to the others.
Is Potenza FDA-cleared or approved?
Cleared. Potenza went through the 510(k) route, which ends in clearance rather than approval. Its cleared use is electrocoagulation and hemostasis in dermatologic and general surgical procedures.
Is RF microneedling still worth considering?
For the right concern, yes. For acne scars, randomised evidence shows benefit with relatively short recovery; see Potenza for acne scars. The notice is a reason to choose the provider and settings carefully.
References
Bibliographic records retrieved from PubMed (U.S. National Library of Medicine).
Chou M, Myers B, Avram M. Analysis of US Food and Drug Administration Data on Radiofrequency Microneedling Device Complications. Dermatol Surg. 2026;52(9):873-876.
Camacho-Hubbard I, Ibrahimi OA, Mariwalla K, et al. Safety Considerations and Complications With Radiofrequency Microneedling: A Cross-Sectional Analysis of the US FDA MAUDE Database. Dermatol Surg. 2026;52(9):867-872.
Syder NC, Chen A, Elbuluk N. Radiofrequency and Radiofrequency Microneedling in Skin of Color: A Review of Usage, Safety, and Efficacy. Dermatol Surg. 2023;49(5):489-493.