Cleared Traditional

K093951 - OUCHLESS MODEL PN10114

K093951 · Occam Design · Physical Medicine device
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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.

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
58d slower than avg
Panel avg: 116d · 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 24
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K093951 · OUCHLESS MODEL PN10114
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