DERMAFREEZE— 510(k) K992286

Name: FDA 510(k) clearance K992286
Creator: U.S. Food and Drug Administration
Published: 2000-01-21

Substantially Equivalent

Rhealm Pharmaceuticals, Inc.

FDA 510(k) clearance K992286 for DERMAFREEZE, Substantially Equivalent on 2000-01-21. Applicant: Rhealm Pharmaceuticals, Inc.. Device class: Unclassified.

Clearance details

Applicant: Rhealm Pharmaceuticals, Inc.
Product code: Code MLY
Device class: Unclassified
Advisory panel: Unknown
Date received: 1999-07-07
Decision date: 2000-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delray Beach, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MLY

view all

K261684 — FreezeSpray TA2026-09-05
K260870 — Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)2026-08-27
K243654 — DentalJect2025-05-30
K232674 — PainFreeze II2024-02-12
K203661 — CRYO Arctic, CRYO Penguin2022-05-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.