Cleared Traditional

K992286 - DERMAFREEZE

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

FDA 510(k) Submission Details - K992286

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 115d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

MLY Device Classification - Class 0,

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 13
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