Cleared Traditional

DERMAFREEZE (K992286) - FDA 510(k) Clearance

K992286 · Rhealm Pharmaceuticals, Inc. · Physical Medicine device
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Jan 2000
Decision
198d
Days
-
Risk

K992286 is an FDA 510(k) clearance for the DERMAFREEZE. Classified as Vapocoolant Device (product code MLY).

Submitted by Rhealm Pharmaceuticals, Inc. (Delray Beach, US). The FDA issued a Cleared decision on January 21, 2000 after a review of 198 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 Rhealm Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K992286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1999
Decision Date January 21, 2000
Days to Decision 198 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
83d slower than avg
Panel avg: 115d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 22
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