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

Name: FDA 510(k) clearance K161434
Creator: U.S. Food and Drug Administration
Published: 2017-09-28

Substantially Equivalent

Li-Tek Electronics Technologies

FDA 510(k) clearance K161434 for Photon Vibrating massage Facial Aesthetic Device (Model: UI-200), Substantially Equivalent on 2017-09-28. Applicant: Li-Tek Electronics Technologies. Device class: 2.

Clearance details

Applicant: Li-Tek Electronics Technologies
Product code: Code OLP
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2016-05-24
Decision date: 2017-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan City, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OLP

product code OLP

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.