Cleared Special

K230506 - PureLift Pro Edition (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230506 · Xtreem Pulse · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
117d
Days
Class 2
Risk

K230506 is an FDA 510(k) clearance for the PureLift Pro Edition. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Xtreem Pulse (New York, US). The FDA issued a Cleared decision on June 21, 2023 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Xtreem Pulse devices

Submission Details

510(k) Number K230506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2023
Decision Date June 21, 2023
Days to Decision 117 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 148d · This submission: 117d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 74
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