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RF microneedling

Morpheus8

InMode Ltd. (510(k) applicant: InMode MD Ltd.)

FDA-cleared device (510(k)) — cleared, not approvedChecked Sep 14, 2026 · Read on the pages cited

What it is

Maker
InMode Ltd. (510(k) applicant: InMode MD Ltd.)
Category
RF microneedling
Also called
InMode Morpheus8, Morpheus 8, Fractora

FDA status

Pathway
FDA-cleared device (510(k)) — cleared, not approved
First approved or cleared
2019

Research notes

K192695 cleared 2019-12-27 (21 CFR 878.4400, electrosurgical cutting and coagulation device, product code GEI). The cleared indication is electrocoagulation and hemostasis; it does not mention skin tightening, wrinkles, acne scars, fat or cellulite. Later InMode clearances for Morpheus8 applicators exist (e.g., K231790, 2023-07-20, seen in openFDA) but their indications were not opened. FDA safety communication dated 2025-10-15 warns of reports of serious complications with RF microneedling for dermatologic/aesthetic procedures, including burns, scarring, fat loss, disfigurement and nerve damage.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Dermatologic and general surgical procedures for electrocoagulation (heat coagulation of tissue) and hemostasis (stopping bleeding)
  • Limitation in the clearance: at energy levels above 62 mJ/pin, use is limited to Skin Types I-IV

How it’s sold

How it’s sold isn’t recorded for this entry.

What the label warns about

No label warning is recorded here. That isn’t the same as the label having none — the research notes and sources say what was opened.

Checking it’s the real thing

No FDA authenticity notice is recorded for this product.

Ask in the room

“What’s the brand name printed on the box, vial or device panel — and may I see it?”

Recalls and enforcement

FDA recall and enforcement records filed under K192695, read live from openFDA. A recall usually covers particular models or lots, not every unit ever made.

Searching FDA recall and enforcement records by this product’s FDA number…

Look up K192695 and a number from the box

What changed at the source

Dated FDA records that concern Morpheus8, newest first. A record says what happened at the source; it is not a finding about any clinic's stock.

  1. Safety communication ·

    FDA safety communication on certain uses of RF microneedling

    U.S. Food & Drug Administration · FDA safety communication, 2025-10-15

    FDA reported serious complications with certain uses of radiofrequency microneedling, including burns, scarring, fat loss, disfigurement and nerve damage, described RF microneedling as a medical procedure rather than a cosmetic treatment, and pointed readers to the exact device's FDA record.

    What this source establishes
    That FDA has received reports of serious complications with certain uses of RF microneedling and considers it a medical procedure.
    What it does not establish
    That any particular device or clinic is unsafe, or anything about an individual reader's risk.

    The official record (opens in a new tab) · checked Sep 25, 2026

Check it yourself

Device proof ladder: The room sells a laser, RF, microneedling, body-contouring, light, or other hardware result. Work down in order — each step needs the one before it.

  1. Read the panelGet the exact manufacturer and model from the device itself.
  2. Find the authorizationSearch 510(k) and De Novo by model/manufacturer, not treatment nickname.510(k) Premarket Notification database (opens in a new tab) · U.S. Food & Drug Administration
  3. Match identityUse AccessGUDID when a UDI or device identifier is available.AccessGUDID (opens in a new tab) · FDA / National Library of Medicine
  4. Read maker instructionsCompare the proposed use with current manufacturer labeling/IFU for that exact model.
  5. Check post-market recordSearch recalls/corrections after the model is known.Medical Device Recalls (opens in a new tab) · U.S. Food & Drug Administration
  6. Verify the operatorThen check the person's applicable state credential and device-specific training.

Worth knowing

What an FDA record can and can’t tell you

FDA records show what was authorized, for what, and when.

They can’t show that the product in the room is authentic, in date, stored properly, or being used for its authorized purpose. Those are questions for the room.

Sources

  1. FDA 510(k) database: K192695 (InMode System with the Morpheus8 (Fractora) Applicators) (opens in a new tab)FDA database
  2. FDA 510(k) clearance letter and summary, K192695 (opens in a new tab)FDA database
  3. FDA Safety Communication: Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling (opens in a new tab)FDA notice

Checked Sep 14, 2026 · Read on the pages cited.

Treatments that use it

Product identity

Told a name? Shown a box?

Type what was said or printed, see whether it matches a registry entry, and note what you saw in your booking file.

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