Cleared Traditional

K022104 - DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ (FDA 510(k) Clearance)

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

K022104 · Daavlin Distributing Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
74d
Days
Class 2
Risk

K022104 is an FDA 510(k) clearance for the DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NA.... 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, 2002 after a review of 74 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

Submission Details

510(k) Number K022104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2002
Decision Date September 10, 2002
Days to Decision 74 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
40d faster than avg
Panel avg: 114d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 271
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