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Ultrasound devices

Ultherapy (Ulthera System)

Ulthera, Inc.

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

What it is

Maker
Ulthera, Inc.
Category
Ultrasound devices
Also called
Ultherapy, Ulthera, Ulthera System, DeepSEE

FDA status

Pathway
FDA-cleared device (510(k)) — cleared, not approved
First approved or cleared
2009

Research notes

The device type was first authorized through De Novo DEN080006, granted 2009-09-11 (regulation 21 CFR 878.4590, focused ultrasound for tissue heat or mechanical cellular disruption, product code OHV); the De Novo's original indication text was not opened. Indications above are from 510(k) K243035, cleared 2025-02-24, which expanded indications. openFDA lists a later Ulthera 510(k), K260618 (2026-05-21), not opened. No device labeling was opened, so no warnings are recorded.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Applies focused ultrasound energy to achieve temporary changes in the physical appearance of the skin
  • Non-invasive aesthetic treatment to lift the eyebrow
  • Lift lax skin under the chin and on the neck, which can also affect the appearance of lax tissue there
  • Improve lines and wrinkles of the décolleté (upper chest)
  • Improve the appearance of skin laxity on the abdomen and the front and back of the arms
  • With the DeepSEE transducer, ultrasound imaging up to 8 mm below the skin to check transducer contact and confirm treatment depth (for example, to avoid bone)

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 K243035, 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 K243035 and a number from the box

What changed at the source

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

  1. Approval or clearance ·

    FDA cleared Ultherapy for the appearance of skin laxity on the knees

    U.S. Food & Drug Administration · 510(k) K260618

    510(k) K260618, "Ulthera System Expanded Indications (Knees)", decided May 21, 2026, adds the knees to the cleared indications. Merz announced it on August 11, 2026.

    What this source establishes
    That the cleared indications for this device now include the knees.
    What it does not establish
    Individual results, whether it suits a given person, or which operator credential a state requires.

    The official record (opens in a new tab) · Merz Aesthetics’s announcement (opens in a new tab) (the maker’s words, not the record) · checked Sep 25, 2026

  2. Approval or clearance ·

    FDA cleared Ultherapy PRIME for skin laxity on the abdomen and arms

    U.S. Food & Drug Administration · 510(k) K243035

    510(k) K243035 (Ulthera, Inc., UC-1 Control Unit PRIME), decided February 24, 2025, covers improving the appearance of skin laxity on the abdomen, anterior arms and posterior arms. Merz announced the new indications on November 5, 2025.

    What this source establishes
    That the cleared indications for this device include the abdomen and the front and back of the arms.
    What it does not establish
    Individual results, whether it suits a given person, or which operator credential a state requires.

    The official record (opens in a new tab) · Merz Aesthetics’s announcement (opens in a new tab) (the maker’s words, not the record) · 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: K243035 (Ulthera System) (opens in a new tab)FDA database
  2. FDA 510(k) clearance letter and Indications for Use, K243035 (opens in a new tab)FDA database
  3. FDA De Novo database: DEN080006 (ULTHERA SYSTEM, MODEL 8850-0001) (opens in a new tab)FDA database

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

Treatments that use it

Product identity

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