Cleared Traditional

K082731 - ML24000 UVA-1 PHOTOTHERAPY CABINET

K082731 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 Traditional 510(k) pathway after a 90-day FDA review.

K082731 · Daavlin Distributing Co. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
90d
Days
Class 2
Risk

K082731 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 December 17, 2008 after a review of 90 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K082731

510(k) Number K082731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2008
Decision Date December 17, 2008
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 154
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K082731.
1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
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K073503 · Diomedics, Inc. · Jan 2008
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K073587 · Daavlin Distributing Co. · Jan 2008
308 DERMATOLOGICAL EXCIMER SYSTEM
K073066 · Quantel Medical, Inc. · Dec 2007
K082731 · ML24000 UVA-1 PHOTOTHERAPY CABINET
Download PDF FDA Summary Daavlin Distributing …