Cleared Traditional

K093951 - OUCHLESS MODEL PN10114

K093951 · Occam Design · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
174d
Days
-
Risk

K093951 is an FDA 510(k) clearance for the OUCHLESS MODEL PN10114. Classified as Vapocoolant Device (product code MLY).

Submitted by Occam Design (Louisville, US). The FDA issued a Cleared decision on June 15, 2010 after a review of 174 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 Occam Design devices

FDA 510(k) Submission Details - K093951

510(k) Number K093951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2009
Decision Date June 15, 2010
Days to Decision 174 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 115d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

MLY Device Classification - Class 0,

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 9
Devices cleared under the same product code (MLY) and FDA review panel - the closest regulatory comparables to K093951.
Vapocoolshot Mist
K193349 · Vapocoolshot, Inc. · Apr 2020
Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray
K190161 · Gebauer Company · May 2019
Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE
K172598 · Itw Contamination Control Electronics · Apr 2018