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PureLift

by Xtreem Pulse, LLC

510(k) K190269

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190269 Date28 Aug 2019ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NFO
Device class
Class II
Regulation
21 CFR Part 882.5890
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

PureLift is a transcutaneous electrical stimulator intended for aesthetic purposes. It is classified as a Class II medical device under regulation number 882.5890.

The device received FDA 510(k) clearance (K190269) on August 28, 2019, and is substantially equivalent to a predicate device. It is manufactured by Xtreem Pulse, LLC and is indicated for use in neurology-related applications as per the advisory committee classification.

Devices cleared under K190269

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K190269
UDI-DISize and differences
PURELIFT FACE
Xtreem Pulse, LLC
PURELIFT FACE / FACE00860008851024
Height 1.4 in; Width 4.8 in; Outer Diameter 4.3 in
On the market

Similar devices

Other devices filed under FDA product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

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