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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 the device name listed in this FDA 510(k) record. The listed applicant is R2 Dermatology. It received FDA 510(k) clearance on 2016-10-05 under 510(k) 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. The listed applicant is R2 Dermatology. The 510(k) number is K161480.

When did R2 Dermal Cooling System receive FDA 510(k) clearance?

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

Who is the listed applicant for R2 Dermal Cooling System?

The FDA 510(k) record lists R2 Dermatology as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing R2 Dermatology as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171398Dermal Cooling System

Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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