Cleared Special

K060859 - COMPOUND W FREEZE OFF WART REMOVAL SYSTEM (FDA 510(k) Clearance)

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

K060859 · OraSure Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
112d
Days
Class 2
Risk

K060859 is an FDA 510(k) clearance for the COMPOUND W FREEZE OFF WART REMOVAL SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on July 18, 2006 after a review of 112 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all OraSure Technologies, Inc. devices

Submission Details

510(k) Number K060859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2006
Decision Date July 18, 2006
Days to Decision 112 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 114d · This submission: 112d
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 K060859.
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