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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Nuon Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-09-05 under 510(k) 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. The listed applicant is Shenzhen Nuon Medical Equipment Co., Ltd.. The 510(k) number is K241155.

When did Cold Sore Device (QPZ-03) receive FDA 510(k) clearance?

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

Who is the listed applicant for Cold Sore Device (QPZ-03)?

The FDA 510(k) record lists Shenzhen Nuon Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Shenzhen Nuon Medical Equipment Co., Ltd. as applicant

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.

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)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)

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.K222205Cold Sore Device (Model: QPZ-01)Light Tree Ventures Europe B.V.

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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