Cleared Traditional

K171398 - Dermal Cooling System

K171398 is an FDA 510(k) clearance for Dermal Cooling System, manufactured by R2 Dermatology ,Inc. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K171398 · R2 Dermatology ,Inc · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
55d
Days
Class 2
Risk

K171398 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 Dermatology ,Inc (San Ramon, US). The FDA issued a Cleared decision on July 6, 2017 after a review of 55 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.

FDA 510(k) Submission Details - K171398

510(k) Number K171398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2017
Decision Date July 06, 2017
Days to Decision 55 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
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEH Device Classification - Class 2, Special Controls

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 239
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K171398.
CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED
K172049 · Cry IQ AB · Aug 2017
truFreeze System
K172041 · CSA Medical, Inc. · Jul 2017
truFreeze Rapid AV Spray Kit
K171522 · CSA Medical, Inc. · Jul 2017
truFreeze System
K163244 · CSA Medical, Inc. · May 2017
ClariFix Device
K162608 · Arrinex, Inc. · Feb 2017
C2 Cryoballoon Ablation System
K161202 · C2 Therapeutics, Inc. · Jan 2017