Cleared Special

K151795 - ML24000 UVA-1 Phototherapy Cabinet

K151795 is an FDA 510(k) clearance for ML24000 UVA-1 Phototherapy Cabinet, manufactured by Daavlin Distributing Co.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Special 510(k) pathway after a 70-day FDA review.

K151795 · Daavlin Distributing Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Sep 2015
Decision
70d
Days
Class 2
Risk

K151795 is an FDA 510(k) clearance for the ML24000 UVA-1 Phototherapy Cabinet. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Daavlin Distributing Co. (Bryan, US). The FDA issued a Cleared decision on September 10, 2015 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4630 - 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 Daavlin Distributing Co. devices

FDA 510(k) Submission Details - K151795

510(k) Number K151795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2015
Decision Date September 10, 2015
Days to Decision 70 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

FTC Device Classification - Class 2, Special Controls

Product Code FTC Light, Ultraviolet, Dermatological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4630
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 - FTC Light, Ultraviolet, Dermatological

All 52
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K151795.
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