Cleared Traditional

K213294 - Dermal Cooling System (FDA 510(k) Clearance)

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

K213294 · R2 Technologies, Inc. · General & Plastic Surgery device
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Nov 2022
Decision
405d
Days
Class 2
Risk

K213294 is an FDA 510(k) clearance for the Dermal Cooling System. Classified as Contact Cooling For Skin Lesion Pain Relief (product code QPZ), Class II - Special Controls.

Submitted by R2 Technologies, Inc. (San Ramon, US). The FDA issued a Cleared decision on November 10, 2022 after a review of 405 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4340 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all R2 Technologies, Inc. devices

Submission Details

510(k) Number K213294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2021
Decision Date November 10, 2022
Days to Decision 405 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
291d slower than avg
Panel avg: 114d · This submission: 405d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QPZ Contact Cooling For Skin Lesion Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4340
Definition For Use In Dermatologic Procedures For The Removal Of Benign Lesions Of The Skin And For Use When Cooling Is Intended For The Temporary Reduction Of Pain, Swelling, Inflammation, And Hematoma From Minor Surgical Procedures.
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.