Cleared Traditional

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

K232674 · Nuance Medical, LLC · Physical Medicine device
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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.

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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 -