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Spa Intelligence

Try a real question: “Who can inject Botox in Montana?” or “Is $12 per unit the full price?” The index loads on first use; what you type is matched in this browser.

Product identity

What was that, exactly?

Type the name as it was said to you or printed on the box — or a number from it: an NDC, a device identifier or full UDI, a 510(k), PMA or application number. A name is matched against this site’s registry; a number can be looked up in FDA’s own records, with any recall filed under it. A match says a record exists. It never says the vial or device in front of you is that product.

Names are matched in this browser, against a copy of the registry that loaded with the page. Only when you press a lookup button is anything sent: that one name or number, to this site, which asks FDA.

Try:

A 510(k) number. Press the lookup button to search FDA records.

Registry match

Ultherapy (Ulthera System)

Ulthera, Inc. · Ultrasound devices

FDA-cleared device (510(k)) — cleared, not approvedK243035 (opens in a new tab)

What it’s authorized for

  • 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)

And 2 more on the full page.

Checking it’s the real thing

No FDA authenticity notice is recorded for this product. Ask: “What’s the brand name printed on the box, vial or device panel — and may I see it?”

Checked Sep 14, 2026

Full page: label warnings, how it’s sold, sources

Official records

This looks like a 510(k) number.

Look it up in FDA and National Library of Medicine databases: the record it belongs to, who holds it, and any recall or enforcement report filed under it.

Sends only “K243035” to this site, which asks FDA and the National Library of Medicine. Nothing else on this page or in your Booking File is sent, and nothing is stored.

Your booking file

Record what you found

Did you see Ultherapy (Ulthera System) itself — the box, vial or device panel?

Your file lives in this browser. Recording waits until it has been read.