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FDA 510(k)

R2 Dermal Cooling System

K-Number: K161480 · 2016-10-05

ApplicantR2 Dermatology
Decision Date2016-10-05
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

R2 Dermal Cooling System is a medical device manufactured by R2 Dermatology. It received FDA 510(k) clearance on 2016-10-05 under approval number K161480. 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 R2 Dermal Cooling System?

R2 Dermal Cooling System is a medical device that received FDA 510(k) clearance on 2016-10-05. It is manufactured by R2 Dermatology. The 510(k) number is K161480.

When was R2 Dermal Cooling System approved by the FDA?

R2 Dermal Cooling System received FDA 510(k) clearance on 2016-10-05, under approval number K161480.

What company makes R2 Dermal Cooling System?

R2 Dermal Cooling System is manufactured by R2 Dermatology.

What is the FDA product code for R2 Dermal Cooling System?

The FDA product code for R2 Dermal Cooling System is GEH.

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Official Source

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

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