Cleared Traditional

K161434 - Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) (FDA 510(k) Clearance)

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

K161434 · Li-Tek Electronics Technologies · General & Plastic Surgery device
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Sep 2017
Decision
492d
Days
Class 2
Risk

K161434 is an FDA 510(k) clearance for the Photon Vibrating massage Facial Aesthetic Device (Model: UI-200). Classified as Over-the-counter Powered Light Based Laser For Acne (product code OLP), Class II - Special Controls.

Submitted by Li-Tek Electronics Technologies (Dongguan City, CN). The FDA issued a Cleared decision on September 28, 2017 after a review of 492 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Li-Tek Electronics Technologies devices

Submission Details

510(k) Number K161434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2016
Decision Date September 28, 2017
Days to Decision 492 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
378d slower than avg
Panel avg: 114d · This submission: 492d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLP Over-the-counter Powered Light Based Laser For Acne
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulgaris.
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 - OLP Over-the-counter Powered Light Based Laser For Acne

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