Cleared Traditional

CryoFreeze Wart and Skin Tag Remover (K243487) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243487 · Cryosurgery, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
125d
Days
Class 2
Risk

K243487 is an FDA 510(k) clearance for the CryoFreeze Wart and Skin Tag Remover. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Cryosurgery, Inc. (Nashville, US). The FDA issued a Cleared decision on March 13, 2025 after a review of 125 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery device framework. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cryosurgery, Inc. devices

Submission Details

510(k) Number K243487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2024
Decision Date March 13, 2025
Days to Decision 125 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 115d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 64
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K243487.
Verruca-Freeze H Plus
K252903 · Cryosurgery, Inc. · Oct 2025
Skin Clinic Freeze Point for Warts and Skin Tags
K251493 · Cryoconcepts LP · May 2025
Skin Clinic Nitro Clear Wart Remover
K242932 · Cryoconcepts LP · Apr 2025
Co-Ablation System with Sterile Co-Ablation Probe
K243042 · Hygea Medical Technology Co., Ltd. · Jan 2025
Advanced Cryo Wart Remover
K242288 · Medical Brands Laboratories B.V. · Jan 2025
Verruca-Freeze H
K243454 · Cryosurgery, Inc. · Dec 2024