Cleared Traditional

K193349 - Vapocoolshot Mist (FDA 510(k) Clearance)

K193349 · Vapocoolshot, Inc. · Physical Medicine device
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Apr 2020
Decision
133d
Days
-
Risk

K193349 is an FDA 510(k) clearance for the Vapocoolshot Mist. Classified as Vapocoolant Device (product code MLY).

Submitted by Vapocoolshot, Inc. (Jupiter, US). The FDA issued a Cleared decision on April 14, 2020 after a review of 133 days - within the typical 510(k) review window.

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 Vapocoolshot, Inc. devices

Submission Details

510(k) Number K193349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2019
Decision Date April 14, 2020
Days to Decision 133 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -