DeviceClearance

Ulike Reglow Light Therapy Device (UM10)— 510(k) K260511

Substantially Equivalent

Shenzhen Ulike Smart Electronics Co., Ltd.

FDA 510(k) clearance K260511 for Ulike Reglow Light Therapy Device (UM10), Substantially Equivalent on 2026-03-16. Applicant: Shenzhen Ulike Smart Electronics Co., Ltd.. Device class: 2.

Summary

Shenzhen Ulike Smart Electronics' Ulike Reglow Light Therapy Device (UM10) is filed under OHS, light-based over-the-counter wrinkle reduction. The record doesn't describe the device beyond its name and that code name.

Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. It was a Special 510(k).

Shenzhen Ulike Smart Electronics filed from Shenzhen, China. The decision came 27 calendar days after receipt (February 17 to March 16, 2026).

Clearance details

Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
Product code
Product code OHS
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Shenzhen, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OHS

product code OHS
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.