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Cold Sore Device (Model QPZ-01)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222205

by Light Tree Ventures Europe B.V.

Identifiers

510(k) Number
K222205 FDA 510(k)
FDA Product Code
OKJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4860 FDA 510(k)
Regulation Number
878.4860 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cold Sore Device (Model QPZ-01) is a Light-Based Treatment for Cold Sores (Herpes Simplex Virus-1) classified under FDA Product Code OKJ. This device is designed to deliver targeted light therapy to reduce the duration and severity of cold sore outbreaks by accelerating lesion healing through photodynamic or photothermal mechanisms.

The device is supplied as a single-use, non-sterile medical instrument intended for home or clinical use. It requires no special storage conditions beyond protection from physical damage and extreme temperatures. Authorised under FDA 510(k) clearance (K222205) as substantially equivalent to predicate devices, it falls under FDA Class II regulation (21 CFR 878.4860) and is reviewed by the General, Plastic Surgery Subpart E advisory committee.

Frequently asked questions

What is the Cold Sore Device (Model QPZ-01) designed to do and how does it work?

The Cold Sore Device (Model QPZ-01) is a light-based treatment intended to reduce the duration and severity of cold sore outbreaks caused by Herpes Simplex Virus-1. It works by delivering targeted light therapy to accelerate lesion healing through mechanisms like photodynamic or photothermal effects, effectively shortening recovery time.

Is the Cold Sore Device (Model QPZ-01) meant for use at home or only in a clinical setting?

The device is explicitly designed for both home and clinical use, as stated in its description. This flexibility allows patients to treat cold sores conveniently in their own environment while also accommodating professional healthcare settings.

How should I store the Cold Sore Device (Model QPZ-01) before use?

No special storage conditions are required beyond protecting the device from physical damage and extreme temperatures. This makes it easy to store at room temperature until ready for use.

Is the Cold Sore Device (Model QPZ-01) single-use or reusable?

The device is classified as single-use and non-sterile, meaning it is intended for one-time use per treatment cycle. This design ensures hygiene and safety for each application.

What regulatory pathway was followed for the FDA clearance of the Cold Sore Device (Model QPZ-01)?

The device received FDA clearance through a traditional 510(k) process, determined to be substantially equivalent to predicate devices. It is classified under FDA Class II (21 CFR 878.4860) and reviewed by the General, Plastic Surgery Subpart E advisory committee, ensuring compliance with established safety and effectiveness standards.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K222205 FDA 510 (k) - Cold Sore Device (Model: QPZ-01), Cold Sore Device (Model: QPZ-01) (K222205) — FDA 510(k) | Innolitics, COLD CULTURE™ | STREETWEAR CLOTHING BRAND, K222205 - Cold Sore Device (Model: QPZ-01) FDA 510 (k) APPLICATION FOR ..., Cold Sore Device (Model: QPZ-01) - BEUDAMED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Light Tree Ventures Europe B.V.

Sources (1)

  • FDA 510(k) K222205 24 fields · synced Sep 19, 2026