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Radiofrequency devices

Thermage FLX

Solta Medical

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

What it is

Maker
Solta Medical
Category
Radiofrequency devices
Also called
Thermage, Thermage FLX System, ThermaCool

FDA status

Pathway
FDA-cleared device (510(k)) — cleared, not approved
First approved or cleared
2000

Research notes

Thermage FLX cleared 2017-09-22 (21 CFR 878.4400, product code GEI). The year 2000 refers to the earliest Thermage-brand clearance found and opened: THERMAGE THERMACOOL SYSTEM, K000944, cleared 2000-07-19 to Thermage, Inc.; that earlier system's indications were not opened. 'Skin tightening' does not appear in the K170758 indication text.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Radiofrequency-only components: dermatologic and general surgical procedures for electrocoagulation and hemostasis
  • Radiofrequency-only components: non-invasive treatment of wrinkles, including wrinkles around the eyes and on the upper and lower eyelids
  • Radiofrequency with skin vibration: the same uses, plus temporary improvement in the appearance of cellulite, relief of minor muscle aches, pains and spasms, and temporary improvement of local blood circulation

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 K170758, 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 K170758 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: K170758 (Thermage FLX System and Accessories) (opens in a new tab)FDA database
  2. FDA 510(k) clearance letter and Indications for Use, K170758 (opens in a new tab)FDA database
  3. FDA 510(k) database: K000944 (THERMAGE THERMACOOL SYSTEM) (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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