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FDA 510(k)

FAQ™ (LED Panel); FAQ™ (Dual LED Panel)

K-Number: K253683 · 2026-02-20

ApplicantForeo, Inc.
Decision Date2026-02-20
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FAQ™ (LED Panel); FAQ™ (Dual LED Panel) is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2026-02-20 under 510(k) number K253683. 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™ (LED Panel); FAQ™ (Dual LED Panel)?

FAQ™ (LED Panel); FAQ™ (Dual LED Panel) is a medical device that received FDA 510(k) clearance on 2026-02-20. The listed applicant is Foreo, Inc.. The 510(k) number is K253683.

When did FAQ™ (LED Panel); FAQ™ (Dual LED Panel) receive FDA 510(k) clearance?

FAQ™ (LED Panel); FAQ™ (Dual LED Panel) received FDA 510(k) clearance on 2026-02-20, under 510(k) number K253683.

Who is the listed applicant for FAQ™ (LED Panel); FAQ™ (Dual LED Panel)?

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™ (LED Panel); FAQ™ (Dual LED Panel)?

The FDA product code for FAQ™ (LED Panel); FAQ™ (Dual LED Panel) 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.

K242747FAQ™ (302)K241102Luna 4 plusK240616FAQ™ (102)K232242BEAR 2 BodyK240378FAQ™ 201, FAQ™ 202K231977PEACH 2, PEACH 2 Duo, PEACH 2 go

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Related Devices (Code: OHS)

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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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