510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K992286Substantially Equivalent

Dermafreeze

Rhealm Pharmaceuticals, Inc., Delray Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992286 is the FDA 510(k) clearance record for DERMAFREEZE, cleared for Rhealm Pharmaceuticals, Inc. on under FDA product code MLY (Vapocoolant Device). FDA records list one 510(k) clearance for Rhealm Pharmaceuticals, Inc. As of , FDA records show no recalls naming K992286.

Clearance record

Decision date
Received
(198 days to decision)
Product code
MLY Vapocoolant Device
Device class
Unclassified
Review panel
Unknown
Applicant
Rhealm Pharmaceuticals, Inc. 258 SE 6th Ave., Suite 12, Delray Beach FL
510(k) summary
Statement
Third party review
No

Clearances, product code MLY

Trailing 12 months
2 clearances under product code MLY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MLY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260