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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

Splendor X

Bios S.R.L. (510(k) applicant) · Lasers

FDA-cleared device (510(k)) — cleared, not approvedK243445 (opens in a new tab)

What it’s authorized for

  • Alexandrite 755 nm: temporary hair reduction, and stable long-term or permanent hair reduction, on all skin types (Fitzpatrick I-VI) including tanned skin
  • Alexandrite 755 nm: benign pigmented lesions and wrinkles, among other listed uses
  • Nd:YAG 1064 nm: removal of unwanted hair for stable long-term or permanent hair reduction and treatment of pseudofolliculitis barbae, on all skin types including tanned skin
  • Nd:YAG 1064 nm: vascular and pigmented lesions, coagulation of soft tissue, reduction of black or blue-black tattoo intensity, redness in hypertrophic and keloid scars, wrinkles, and temporary increase of clear nail in onychomycosis

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?”

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 “K243445” 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 Splendor X itself — the box, vial or device panel?

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