Cleared Traditional

TargetCool™ (K230599) - FDA 510(k) Clearance

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

K230599 · Recensmedical, Inc. · General & Plastic Surgery device
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Jun 2023
Decision
111d
Days
Class 2
Risk

K230599 is an FDA 510(k) clearance for the TargetCool™. 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 June 22, 2023 after a review of 111 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 Recensmedical, Inc. devices

Submission Details

510(k) Number K230599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2023
Decision Date June 22, 2023
Days to Decision 111 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
4d faster than avg
Panel avg: 115d · This submission: 111d
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
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