FDA 510(k)

ClearCorrect System

K-Number: K210320 · 2021-08-06

Decision Date2021-08-06

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ClearCorrect System is the device name listed in this FDA 510(k) record. The listed applicant is Clearcorrect, LLC. It received FDA 510(k) clearance on 2021-08-06 under 510(k) number K210320. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearCorrect System?

ClearCorrect System is a medical device that received FDA 510(k) clearance on 2021-08-06. The listed applicant is Clearcorrect, LLC. The 510(k) number is K210320.

When did ClearCorrect System receive FDA 510(k) clearance?

ClearCorrect System received FDA 510(k) clearance on 2021-08-06, under 510(k) number K210320.

Who is the listed applicant for ClearCorrect System?

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

What is the FDA product code for ClearCorrect System?

The FDA product code for ClearCorrect System is NXC.

Other records listing Clearcorrect, LLC 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.

K220140ClearCorrect System

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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.