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FDA 510(k)

Cold Sore Device (Model: QPZ-01)

K-Number: K222205 · 2022-10-07

ApplicantLight Tree Ventures Europe B.V.
Decision Date2022-10-07
Product CodeOKJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cold Sore Device (Model: QPZ-01) is the device name listed in this FDA 510(k) record. The listed applicant is Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2022-10-07 under 510(k) 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. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K222205.

When did Cold Sore Device (Model: QPZ-01) receive FDA 510(k) clearance?

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

Who is the listed applicant for Cold Sore Device (Model: QPZ-01)?

The FDA 510(k) record lists Light Tree Ventures Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: OKJ)

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.

K251973Luminance Red Cold Sore Device (TN1927G)Luminance Medical Ventures, Inc.K241155Cold Sore Device (QPZ-03)Shenzhen Nuon Medical Equipment Co., Ltd.

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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