Cleared Traditional

K252960 - SOLIUS PRO UVB Light Panel (FDA 510(k) Clearance)

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

K252960 · Solius Labs, Inc. · General & Plastic Surgery device
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Jan 2026
Decision
122d
Days
Class 2
Risk

K252960 is an FDA 510(k) clearance for the SOLIUS PRO UVB Light Panel. Classified as Ultraviolet Lamp Products (product code SGZ), Class II - Special Controls.

Submitted by Solius Labs, Inc. (Bainbridge Island, US). The FDA issued a Cleared decision on January 16, 2026 after a review of 122 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4635 - 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 Solius Labs, Inc. devices

Submission Details

510(k) Number K252960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2025
Decision Date January 16, 2026
Days to Decision 122 days
Submission Type Traditional
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
8d slower than avg
Panel avg: 114d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SGZ Ultraviolet Lamp Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4635
Definition An Ultraviolet Lamp Product Intended To Stimulate The Production Of Vitamin D
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 Consultant

Bentley Biomedical Consulting, LLC
Shepard Bentley

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.