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FDA 510(k)

Dermal Cooling System

K-Number: K201260 · 2020-09-24

ApplicantR2 Technologies, Inc.
Decision Date2020-09-24
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dermal Cooling System is a medical device manufactured by R2 Technologies, Inc.. It received FDA 510(k) clearance on 2020-09-24 under approval number K201260. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dermal Cooling System?

Dermal Cooling System is a medical device that received FDA 510(k) clearance on 2020-09-24. It is manufactured by R2 Technologies, Inc.. The 510(k) number is K201260.

When was Dermal Cooling System approved by the FDA?

Dermal Cooling System received FDA 510(k) clearance on 2020-09-24, under approval number K201260.

What company makes Dermal Cooling System?

Dermal Cooling System is manufactured by R2 Technologies, Inc..

What is the FDA product code for Dermal Cooling System?

The FDA product code for Dermal Cooling System is GEH.

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Other Devices by R2 Technologies, Inc.

K203006R2 Dermabrasion Tip (for Dermal Cooling System) K213294Dermal Cooling System

Related Devices (Code: GEH)

K162695truFreeze SystemCSA Medical, Inc. K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical , Ltd. K161480R2 Dermal Cooling SystemR2 Dermatology K161294Compound W Wart Removal System Dual PowerMedtech Products, Inc. K161615AccurettH&O Equipments, Nv/Sa K161557truFreeze SystemCSA Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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