Cleared Special

K260511 - Ulike Reglow Light Therapy Device (UM10) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260511 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery device

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Mar 2026

Decision

27d

Days

Class 2

Risk

K260511 is an FDA 510(k) clearance for the Ulike Reglow Light Therapy Device (UM10). Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Shenzhen Ulike Smart Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 16, 2026 after a review of 27 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Shenzhen Ulike Smart Electronics Co., Ltd. devices

Submission Details

510(k) Number	K260511 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 17, 2026
Decision Date	March 16, 2026
Days to Decision	27 days
Submission Type	Special
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

87d faster than avg

Panel avg: 114d · This submission: 27d

Pathway characteristics

Modification to existing cleared device.

Device Classification

Product Code	OHS Light Based Over The Counter Wrinkle Reduction
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.

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.