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FDA 510(k)

Lorals

K-Number: K212928 · 2022-04-22

ApplicantBrazen Goods Inc. Dba Lorals
Decision Date2022-04-22
Product CodeMSC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Lorals is the device name listed in this FDA 510(k) record. The listed applicant is Brazen Goods Inc. Dba Lorals. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K212928. The device is classified under product code MSC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lorals?

Lorals is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Brazen Goods Inc. Dba Lorals. The 510(k) number is K212928.

When did Lorals receive FDA 510(k) clearance?

Lorals received FDA 510(k) clearance on 2022-04-22, under 510(k) number K212928.

Who is the listed applicant for Lorals?

The FDA 510(k) record lists Brazen Goods Inc. Dba Lorals as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lorals?

The FDA product code for Lorals is MSC.

Related Devices (Code: MSC)

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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