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Electromagnetic devices

Emsculpt NEO

BTL Industries

FDA status not confirmedChecked Sep 14, 2026 · Partly confirmed

What it is

Maker
BTL Industries
Category
Electromagnetic devices
Also called
Emsculpt Neo, EMSCULPT NEO, Emsculpt, HIFEM

FDA status

No FDA pathway is on file for this entry. That is not a clearance, and it is not a finding that FDA has no record.

UNVERIFIED LINK BETWEEN TRADE NAME AND CLEARANCE. BTL's FDA 510(k) records use model numbers rather than brand names. BTL-899 (K192224, cleared 2019-12-05, 21 CFR 878.4400, product code GEI) is indicated for non-invasive lipolysis (fat breakdown) of the abdomen and reduction in abdominal circumference, for Skin Types I-III; its summary describes combining bipolar radiofrequency with electromagnetic stimulation. No opened FDA page states that BTL-899 is marketed as Emsculpt NEO, so it is not recorded as this product's clearance. An FDA MAUDE report for brand EMSCULPT NEO lists product code NGX (powered muscle stimulator) and no 510(k) number. Individual MAUDE reports are unverified and do not establish cause.

Authorized uses on file

No authorized uses are on file, because no FDA pathway is on file. That is not a clearance.

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 this product’s FDA number, 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…

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 MAUDE adverse event report naming brand EMSCULPT NEO (manufacturer BTL Industries JSC) (opens in a new tab)FDA database
  2. FDA 510(k) database: K192224 (BTL-899) (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.

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