Cleared Traditional

Co-Ablation System with Sterile Co-Ablation Probe (K243042) - FDA 510(k) Clearance

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

K243042 · Hygea Medical Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
124d
Days
Class 2
Risk

K243042 is an FDA 510(k) clearance for the Co-Ablation System with Sterile Co-Ablation Probe. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Hygea Medical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on January 29, 2025 after a review of 124 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 Hygea Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K243042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2024
Decision Date January 29, 2025
Days to Decision 124 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
9d slower than avg
Panel avg: 115d · This submission: 124d
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 K243042.
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
CryoFreeze Wart and Skin Tag Remover
K243487 · Cryosurgery, Inc. · Mar 2025
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