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FDA 510(k)

FAQ™ 201, FAQ™ 202

K-Number: K240378 · 2024-04-19

ApplicantForeo, Inc.
Decision Date2024-04-19
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FAQ™ 201, FAQ™ 202 is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K240378. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FAQ™ 201, FAQ™ 202?

FAQ™ 201, FAQ™ 202 is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Foreo, Inc.. The 510(k) number is K240378.

When did FAQ™ 201, FAQ™ 202 receive FDA 510(k) clearance?

FAQ™ 201, FAQ™ 202 received FDA 510(k) clearance on 2024-04-19, under 510(k) number K240378.

Who is the listed applicant for FAQ™ 201, FAQ™ 202?

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

What is the FDA product code for FAQ™ 201, FAQ™ 202?

The FDA product code for FAQ™ 201, FAQ™ 202 is OHS.

Other records listing Foreo, Inc. 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.

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Related Devices (Code: OHS)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.