Cleared Traditional

Dermal Cooling System (K201260) - FDA 510(k) Clearance

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

K201260 · R2 Technologies, Inc. · General & Plastic Surgery device
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Sep 2020
Decision
136d
Days
Class 2
Risk

K201260 is an FDA 510(k) clearance for the Dermal Cooling System. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by R2 Technologies, Inc. (San Ramon, US). The FDA issued a Cleared decision on September 24, 2020 after a review of 136 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 R2 Technologies, Inc. devices

Submission Details

510(k) Number K201260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2020
Decision Date September 24, 2020
Days to Decision 136 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
21d slower than avg
Panel avg: 115d · This submission: 136d
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 K201260.
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K203032 · Galil Medical, Inc. · Nov 2020
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Frozen N
K193665 · Yozma Bmtech Co., Ltd. · May 2020
Cry-Ac®, Cry-Ac-3®, Cry-Baby
K193619 · Brymill Cryogenic Systems · Mar 2020