Cleared Traditional

K223642 - LED Lip Perfector

K223642 is an FDA 510(k) clearance for LED Lip Perfector, manufactured by Light Tree Ventures Europe B.V.. The device is a Class 2 General & Plastic Surgery device with product code ILY cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K223642 · Light Tree Ventures Europe B.V. · General & Plastic Surgery device
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Mar 2023
Decision
93d
Days
Class 2
Risk

K223642 is an FDA 510(k) clearance for the LED Lip Perfector, model: ZC-05. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Light Tree Ventures Europe B.V. (Hague, NL). The FDA issued a Cleared decision on March 9, 2023 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 890.5500 - 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 Light Tree Ventures Europe B.V. devices

FDA 510(k) Submission Details - K223642

510(k) Number K223642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2022
Decision Date March 09, 2023
Days to Decision 93 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

All 27
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