Cleared Traditional

K222205 - Cold Sore Device (Model: QPZ-01) (FDA 510(k) Clearance)

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

K222205 · Light Tree Ventures Europe B.V. · General & Plastic Surgery device
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Oct 2022
Decision
74d
Days
Class 2
Risk

K222205 is an FDA 510(k) clearance for the Cold Sore Device (Model: QPZ-01). Classified as Light Based Treatment For Cold Sores Herpes Simplex Virus-1 (product code OKJ), Class II - Special Controls.

Submitted by Light Tree Ventures Europe B.V. (Hague, NL). The FDA issued a Cleared decision on October 7, 2022 after a review of 74 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Light Tree Ventures Europe B.V. devices

Submission Details

510(k) Number K222205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2022
Decision Date October 07, 2022
Days to Decision 74 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
40d faster than avg
Panel avg: 114d · This submission: 74d
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.