FDA 510(k)

Cold Sore Device (QPZ-03)

K-Number: K241155 · 2024-09-05

ApplicantShenzhen Nuon Medical Equipment Co., Ltd.

Decision Date2024-09-05

Product CodeOKJ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Cold Sore Device (QPZ-03) is a medical device manufactured by Shenzhen Nuon Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-09-05 under approval number K241155. 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 (QPZ-03)?

Cold Sore Device (QPZ-03) is a medical device that received FDA 510(k) clearance on 2024-09-05. It is manufactured by Shenzhen Nuon Medical Equipment Co., Ltd.. The 510(k) number is K241155.

When was Cold Sore Device (QPZ-03) approved by the FDA?

Cold Sore Device (QPZ-03) received FDA 510(k) clearance on 2024-09-05, under approval number K241155.

What company makes Cold Sore Device (QPZ-03)?

Cold Sore Device (QPZ-03) is manufactured by Shenzhen Nuon Medical Equipment Co., Ltd..

What is the FDA product code for Cold Sore Device (QPZ-03)?

The FDA product code for Cold Sore Device (QPZ-03) is OKJ.

Other Devices by Shenzhen Nuon Medical Equipment Co., Ltd.

K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) K241342Hair Growth Comb (SZ-23,SZ-23A) K251034Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)

Related Devices (Code: OKJ)

K222205Cold Sore Device (Model: QPZ-01)Light Tree Ventures Europe B.V. K251973Luminance Red Cold Sore Device (TN1927G)Luminance Medical Ventures, Inc.

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.