Cleared Special

Skin Clinic Freeze Point for Warts and Skin Tags (K251493) - FDA 510(k) Clearance

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

K251493 · Cryoconcepts LP · General & Plastic Surgery device
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May 2025
Decision
7d
Days
Class 2
Risk

K251493 is an FDA 510(k) clearance for the Skin Clinic Freeze Point for Warts and Skin Tags. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Cryoconcepts LP (Easton, US). The FDA issued a Cleared decision on May 22, 2025 after a review of 7 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 Cryoconcepts LP devices

Submission Details

510(k) Number K251493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2025
Decision Date May 22, 2025
Days to Decision 7 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 115d · This submission: 7d
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 64
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K251493.
TargetCool™ (RM-DT02W)
K253114 · Recensmedical, Inc. · Oct 2025
TargetCool-e
K253348 · Recensmedical, Inc. · Oct 2025
Verruca-Freeze H Plus
K252903 · Cryosurgery, Inc. · Oct 2025
Skin Clinic Nitro Clear Wart Remover
K242932 · Cryoconcepts LP · Apr 2025
CryoFreeze Wart and Skin Tag Remover
K243487 · Cryosurgery, Inc. · Mar 2025
Co-Ablation System with Sterile Co-Ablation Probe
K243042 · Hygea Medical Technology Co., Ltd. · Jan 2025