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K Number
K992286
Device Name
DERMAFREEZE
Manufacturer
RHEALM PHARMACEUTICALS, INC.
Date Cleared
2000-01-21

(198 days)

Product Code
MLY
Regulation Number
N/A
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

DermaFreeze™ is a vapocoolant intended for topical application for the control of pain associated with minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), injections, and contusions.

Device Description

DermaFreeze™ is a vapocoolant

AI/ML Overview

I'm sorry, but this document is a 510(k) clearance letter from the FDA for a device called "DermaFreeze™". It is a regulatory document confirming that the device is substantially equivalent to a predicate device already on the market.

This type of document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it relates to the performance of an AI/ML powered device.

Therefore, I cannot extract the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methodology from this document.

N/A