Cleared Traditional

num Vapocoolant (K202782) - FDA 510(k) Clearance

K202782 · 623 Medical, LLC · Physical Medicine device
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Dec 2020
Decision
90d
Days
-
Risk

K202782 is an FDA 510(k) clearance for the num Vapocoolant. Classified as Vapocoolant Device (product code MLY).

Submitted by 623 Medical, LLC (Morrisville, US). The FDA issued a Cleared decision on December 21, 2020 after a review of 90 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 623 Medical, LLC devices

Submission Details

510(k) Number K202782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2020
Decision Date December 21, 2020
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Consultant

Gilero, LLC
James Fentress

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 22
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