Cleared Traditional

K193349 - Vapocoolshot Mist

K193349 · Vapocoolshot, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K193349

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

MLY Device Classification - Class 0,

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Consultant

N2pharma, LLC
Neil Ross

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MLY Vapocoolant Device

All 7
Devices cleared under the same product code (MLY) and FDA review panel - the closest regulatory comparables to K193349.
CRYO Arctic, CRYO Penguin
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num Vapocoolant
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Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE
K172598 · Itw Contamination Control Electronics · Apr 2018