Cleared Traditional

K241155 - Cold Sore Device (QPZ-03) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241155 · Shenzhen Nuon Medical Equipment Co., Ltd. · General & Plastic Surgery device
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Sep 2024
Decision
133d
Days
Class 2
Risk

K241155 is an FDA 510(k) clearance for the Cold Sore Device (QPZ-03). Classified as Light Based Treatment For Cold Sores Herpes Simplex Virus-1 (product code OKJ), Class II - Special Controls.

Submitted by Shenzhen Nuon Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 5, 2024 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4860 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Nuon Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K241155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2024
Decision Date September 05, 2024
Days to Decision 133 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 114d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OKJ Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4860
Definition Shortens Time To Healing Of Herpes Simplex Lesions On The Lips, With Time To Healing Defined As The Time To Patient Described Re-epithelialization.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.