Cleared Traditional

Freeze Point & Private Label Versions (K242625) - FDA 510(k) Clearance

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

K242625 · Cryoconcepts LP · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2024
Decision
52d
Days
Class 2
Risk

K242625 is an FDA 510(k) clearance for the Freeze Point & Private Label Versions. 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 October 25, 2024 after a review of 52 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cryoconcepts LP devices

Submission Details

510(k) Number K242625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2024
Decision Date October 25, 2024
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
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 K242625.
Advanced Cryo Wart Remover
K242288 · Medical Brands Laboratories B.V. · Jan 2025
Verruca-Freeze H
K243454 · Cryosurgery, Inc. · Dec 2024
Compound W Skin Tag Remover
K242803 · Medtech Products, Inc. · Nov 2024
IceSeed 1.5 CX Straight Needle (H7493968333170)
K243245 · Boston Scientific Corp · Oct 2024
Celsio Flexible Cryocatheter System
K240776 · Endocision Technologies, Inc. · Sep 2024
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
K240457 · Pentax of America, Inc. · Jul 2024