Cleared Traditional

K874889 - U.V. SUNLAMP 95 UF-11

K874889 is the FDA 510(k) clearance for U.V. SUNLAMP 95 UF-11 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 29-day FDA review.

K874889 · Light Sources, Inc. · General & Plastic Surgery device
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Dec 1987
Decision
29d
Days
Class 2
Risk

K874889 is an FDA 510(k) clearance for the U.V. SUNLAMP 95 UF-11. 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 December 30, 1987 after a review of 29 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 K874889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1987
Decision Date December 30, 1987
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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.