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Spa Intelligence

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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

Vivace RF microneedling

Sung Hwan E&B Co., Ltd. / ShenB Co., Ltd. (510(k) applicants) · RF microneedling

FDA-cleared device (510(k)) — cleared, not approvedK150409 (opens in a new tab)

What it’s authorized for

  • Dermatologic and general surgical procedures for electrocoagulation and hemostasis
  • Percutaneous (through-the-skin) treatment of facial wrinkles
  • For use with Skin Types I to V

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 “K150409” 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 Vivace RF microneedling itself — the box, vial or device panel?

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