Cleared Traditional

K042502 - 3 SERIES PHOTOTHERAPY CABINET

K042502 is an FDA 510(k) clearance for 3 SERIES 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 30-day FDA review.

K042502 · Daavlin Distributing Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
30d
Days
Class 2
Risk

K042502 is an FDA 510(k) clearance for the 3 SERIES 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 October 14, 2004 after a review of 30 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Daavlin Distributing Co. devices

FDA 510(k) Submission Details - K042502

510(k) Number K042502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2004
Decision Date October 14, 2004
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
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 52
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