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FDA 510(k)

myLEDmask

K-Number: K223147 · 2023-05-14

ApplicantMyblend
Decision Date2023-05-14
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

myLEDmask is a medical device manufactured by Myblend. It received FDA 510(k) clearance on 2023-05-14 under approval number K223147. 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 myLEDmask?

myLEDmask is a medical device that received FDA 510(k) clearance on 2023-05-14. It is manufactured by Myblend. The 510(k) number is K223147.

When was myLEDmask approved by the FDA?

myLEDmask received FDA 510(k) clearance on 2023-05-14, under approval number K223147.

What company makes myLEDmask?

myLEDmask is manufactured by Myblend.

What is the FDA product code for myLEDmask?

The FDA product code for myLEDmask 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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