Cleared Traditional

K901324 - U.V. SUNLAMP 95UF-II

K901324 is the FDA 510(k) clearance for U.V. SUNLAMP 95UF-II by Light Sources, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTC) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K901324 · Light Sources, Inc. · General & Plastic Surgery device
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Apr 1990
Decision
36d
Days
Class 2
Risk

K901324 is an FDA 510(k) clearance for the U.V. SUNLAMP 95UF-II. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Light Sources, Inc. (Ansonia, US). The FDA issued a Cleared decision on April 26, 1990 after a review of 36 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 Light Sources, Inc. devices

Submission Details

510(k) Number K901324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1990
Decision Date April 26, 1990
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
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.