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FDA 510(k)

Cold Sore Device (Model: QPZ-01)

K-Number: K222205 · 2022-10-07

Decision Date2022-10-07
Product CodeOKJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cold Sore Device (Model: QPZ-01) is a medical device manufactured by Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2022-10-07 under approval number K222205. The device is classified under product code OKJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cold Sore Device (Model: QPZ-01)?

Cold Sore Device (Model: QPZ-01) is a medical device that received FDA 510(k) clearance on 2022-10-07. It is manufactured by Light Tree Ventures Europe B.V.. The 510(k) number is K222205.

When was Cold Sore Device (Model: QPZ-01) approved by the FDA?

Cold Sore Device (Model: QPZ-01) received FDA 510(k) clearance on 2022-10-07, under approval number K222205.

What company makes Cold Sore Device (Model: QPZ-01)?

Cold Sore Device (Model: QPZ-01) is manufactured by Light Tree Ventures Europe B.V..

What is the FDA product code for Cold Sore Device (Model: QPZ-01)?

The FDA product code for Cold Sore Device (Model: QPZ-01) is OKJ.

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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.