Cleared Special

K253000 - CryoFreeze Wart and Skin Tag Remover (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253000 · Cryosurgery, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
28d
Days
Class 2
Risk

K253000 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 October 16, 2025 after a review of 28 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cryosurgery, Inc. devices

Submission Details

510(k) Number K253000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2025
Decision Date October 16, 2025
Days to Decision 28 days
Submission Type Special
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
86d faster than avg
Panel avg: 114d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 260
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K253000.
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit
K253230 · Erbe Elektromedizin GmbH · Apr 2026
Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
K252198 · Medical Brands Laboratories B.V. · Apr 2026
XSense Cryoablation System with CryoProbes
K260377 · IceCure Medical , Ltd. · Feb 2026
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01)
K251928 · Medinice S.A. · Feb 2026
Dr. Yglo Skin Tag Remover
K251524 · Theotclab Healthcare B.V. · Jan 2026
Focused Cryotherapy System
K250742 · Focused Cryo, Inc. · Dec 2025