Follicle Clarity— 510(k) K212012

Substantially Equivalent

Cycle Clarity

FDA 510(k) clearance K212012 for Follicle Clarity, Substantially Equivalent on 2022-01-19. Applicant: Cycle Clarity. Device class: 2.

Clearance details

Applicant: Cycle Clarity
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-06-28
Decision date: 2022-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Awendaw, SC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.