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FDA 510(k)

Follicle Clarity

K-Number: K212012 · 2022-01-19

ApplicantCycle Clarity
Decision Date2022-01-19
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Follicle Clarity is the device name listed in this FDA 510(k) record. The listed applicant is Cycle Clarity. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K212012. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Follicle Clarity?

Follicle Clarity is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Cycle Clarity. The 510(k) number is K212012.

When did Follicle Clarity receive FDA 510(k) clearance?

Follicle Clarity received FDA 510(k) clearance on 2022-01-19, under 510(k) number K212012.

Who is the listed applicant for Follicle Clarity?

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

What is the FDA product code for Follicle Clarity?

The FDA product code for Follicle Clarity is QIH.

Related Devices (Code: QIH)

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

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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