Cleared Traditional

TargetCool-e (K253348) - FDA 510(k) Clearance

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

K253348 · Recensmedical, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2025
Decision
15d
Days
Class 2
Risk

K253348 is an FDA 510(k) clearance for the TargetCool-e. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Recensmedical, Inc. (Hwaseong-Si, KR). The FDA issued a Cleared decision on October 15, 2025 after a review of 15 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 Recensmedical, Inc. devices

Submission Details

510(k) Number K253348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date October 15, 2025
Days to Decision 15 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
100d faster than avg
Panel avg: 115d · This submission: 15d
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 K253348.
Focused Cryotherapy System
K250742 · Focused Cryo, Inc. · Dec 2025
CryoFreeze Wart and Skin Tag Remover
K253000 · Cryosurgery, Inc. · Oct 2025
TargetCool™ (RM-DT02W)
K253114 · Recensmedical, Inc. · Oct 2025
Verruca-Freeze H Plus
K252903 · Cryosurgery, Inc. · Oct 2025
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