ARI COLD SPRAY (K033720) - FDA 510(k) Clearance

K033720 is an FDA 510(k) clearance for the ARI COLD SPRAY. Classified as Vapocoolant Device (product code MLY).

Submitted by Ari (Marietta, US). The FDA issued a Cleared decision on June 10, 2005 after a review of 562 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

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