FDA 510(k)

Dermal Cooling System

K-Number: K213294 · 2022-11-10

Decision Date2022-11-10

Product CodeQPZ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Dermal Cooling System is the device name listed in this FDA 510(k) record. The listed applicant is R2 Technologies, Inc.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K213294. The device is classified under product code QPZ. 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 2022-11-10. The listed applicant is R2 Technologies, Inc.. The 510(k) number is K213294.

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

Dermal Cooling System received FDA 510(k) clearance on 2022-11-10, under 510(k) number K213294.

Who is the listed applicant for Dermal Cooling System?

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

What is the FDA product code for Dermal Cooling System?

The FDA product code for Dermal Cooling System is QPZ.

Other records listing R2 Technologies, Inc. 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.

K203006R2 Dermabrasion Tip (for Dermal Cooling System)K201260Dermal Cooling System

Related Devices (Code: QPZ)

K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc.

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.