Skip to content
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.

Lasers

Fraxel laser

Solta Medical

FDA-cleared device (510(k)) — cleared, not approvedChecked Sep 14, 2026 · Partly confirmed

What it is

Maker
Solta Medical
Category
Lasers
Also called
Fraxel, Fraxel FTX, Fraxel Dual, Fraxel re:store, Fraxel Dual 1550/1927

FDA status

Pathway
FDA-cleared device (510(k)) — cleared, not approved
First approved or cleared
2005

Research notes

Clearance records verified: Fraxel FTX Laser System K242142 (Solta Medical, 2024-08-21, 21 CFR 878.4810, product code GEX); Fraxel Dual 1550/1927 K130193 (Solta Medical, 2013-06-14); Fraxel SR K050841 (Reliant Technologies, 2005-07-05), the earliest Fraxel-named clearance found. INDICATIONS UNVERIFIED: the K242142 indications page did not yield extractable text and the K130193 document is a scanned image, so no indication is recorded. A search snippet attributing Fraxel Dual indications to K213332 was wrong; K213332 is Paradigm Medical's 'Multifrax Laser System'. Which Fraxel model a clinic uses matters, as models differ.

What it’s authorized for

The authorized uses weren’t captured from the FDA record. The research notes say why.

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 K242142, 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 K242142 and a number from the box

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: K242142 (Fraxel FTX Laser System) (opens in a new tab)FDA database
  2. FDA 510(k) database: K130193 (FRAXEL DUAL 1550/1927 LASER SYSTEM) (opens in a new tab)FDA database
  3. FDA 510(k) database: K050841 (FRAXEL SR LASER SYSTEM) (opens in a new tab)FDA database

Checked Sep 14, 2026 · Partly confirmed.

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.

Check a name