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FDA 510(k)

Luna 4 plus

K-Number: K241102 · 2024-08-20

ApplicantForeo, Inc.
Decision Date2024-08-20
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Luna 4 plus is a medical device manufactured by Foreo, Inc.. It received FDA 510(k) clearance on 2024-08-20 under approval number K241102. 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 Luna 4 plus?

Luna 4 plus is a medical device that received FDA 510(k) clearance on 2024-08-20. It is manufactured by Foreo, Inc.. The 510(k) number is K241102.

When was Luna 4 plus approved by the FDA?

Luna 4 plus received FDA 510(k) clearance on 2024-08-20, under approval number K241102.

What company makes Luna 4 plus?

Luna 4 plus is manufactured by Foreo, Inc..

What is the FDA product code for Luna 4 plus?

The FDA product code for Luna 4 plus is 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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