Morpheus8: what it is, what the FDA has cleared it for, and the FDA's safety communication

Morpheus8 is a brand of radiofrequency (RF) microneedling device made by InMode. It uses an array of tiny electrode pins to deliver heat energy into the skin.²

The FDA issued a safety communication about RF microneedling in October 2025. Here is what it says, what the FDA has cleared Morpheus8 for, and what to ask a clinic that offers it. Whether to have it is for you and a clinician.

What it is

A 2019 FDA clearance summary describes the Morpheus8 applicators as delivering RF energy to the skin in a fractional manner, through an array of multi-electrode pins.² The FDA describes RF microneedling devices in much the same way: an array of small electrodes, also called microneedles, that deliver RF energy into and under the skin to produce local heating.¹ The FDA's communication doesn't name brands, so this match is our reading of the two documents.

What the FDA has cleared

The FDA's database lists three 510(k) clearances under the name Morpheus8, all to InMode: December 2019, July 2023 and June 2024.² A 510(k) clearance means the FDA found a device substantially equivalent to one already on the market. It isn't the same as approval.¹² The FDA says RF microneedling devices are Class II medical devices cleared this way.¹

The uses the FDA lists in these clearances are narrow and technical. In 2023 and 2024 it is dermatologic procedures where coagulation or contraction of soft tissue, or hemostasis, is needed. In 2019 it is dermatologic and general surgical procedures for electrocoagulation and hemostasis.² These are prescription devices.² The wording doesn't mention wrinkles, acne scars or skin tightening.

The 2023 and 2024 clearances also say that at higher energy levels, use is limited to skin types I to IV.² That refers to the six-type Fitzpatrick scale, which rates how skin reacts to sun. Ask your provider which type they think you are, and what that means for the settings they would use.

The FDA's safety communication

In October 2025 the FDA told consumers, patients and providers that serious complications have been reported with certain uses of RF microneedling devices for skin procedures.¹ The reports include burns, scarring, fat loss, disfigurement and nerve damage, and some people needed surgical repair or other medical care.¹

The FDA's evaluation is ongoing, and it is working with manufacturers.¹

The FDA's advice to patients is to discuss the benefits and risks of all available skin procedures with your provider. If you are considering RF microneedling, it says to seek care from a licensed provider with training and experience in RF microneedling devices, and to ask which devices they plan to use. It also says these devices should not be used at home.¹

How it differs from other microneedling

Regular microneedling devices create small puncture holes in the skin with needles. RF devices add heat through electrodes.¹³ The FDA has authorized specific microneedling devices to improve the appearance of facial acne scars, facial wrinkles and abdominal scars in people aged 22 or older.³ Our microneedling page covers that. Ask whether the device you are offered is a regular or an RF device, since the sources describe them differently.

At the clinics we list

1,343 of the 7,475 med spas we list name Morpheus8. That doesn't show how often they use it, who runs it or whether they follow the FDA's advice, so ask.⁴

Here is what to bring to a consultation.

Cost

We don't give prices on this page. Our microneedling cost guide covers how clinics quote microneedling.

Common questions