Cleared Traditional

PainFreeze II (K232674) - FDA 510(k) Clearance

K232674 · Nuance Medical, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
164d
Days
-
Risk

K232674 is an FDA 510(k) clearance for the PainFreeze II. Classified as Vapocoolant Device (product code MLY).

Submitted by Nuance Medical, LLC (Carlsbad, US). The FDA issued a Cleared decision on February 12, 2024 after a review of 164 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Nuance Medical, LLC devices

Submission Details

510(k) Number K232674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2023
Decision Date February 12, 2024
Days to Decision 164 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 115d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 7
Devices cleared under the same product code (MLY) and FDA review panel - the closest regulatory comparables to K232674.
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