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FDA 510(k)

2 Face / Face Evolution

K-Number: K171821 · 2018-04-26

Decision Date2018-04-26
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

2 Face / Face Evolution is the device name listed in this FDA 510(k) record. The listed applicant is Heat IN A Click. It received FDA 510(k) clearance on 2018-04-26 under 510(k) number K171821. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2 Face / Face Evolution?

2 Face / Face Evolution is a medical device that received FDA 510(k) clearance on 2018-04-26. The listed applicant is Heat IN A Click. The 510(k) number is K171821.

When did 2 Face / Face Evolution receive FDA 510(k) clearance?

2 Face / Face Evolution received FDA 510(k) clearance on 2018-04-26, under 510(k) number K171821.

Who is the listed applicant for 2 Face / Face Evolution?

The FDA 510(k) record lists Heat IN A Click as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2 Face / Face Evolution?

The FDA product code for 2 Face / Face Evolution is NFO.

Other records listing Heat IN A Click 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.

View all 7 devices →

Related Devices (Code: NFO)

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.

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.