Cleared Traditional

MEDICAL SUNLAMP FOR PHOTOTHERAPY (K915426) - FDA 510(k) Clearance

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

K915426 · American Sunlight, Inc. · General & Plastic Surgery device
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Mar 1992
Decision
93d
Days
Class 2
Risk

K915426 is an FDA 510(k) clearance for the MEDICAL SUNLAMP FOR PHOTOTHERAPY. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by American Sunlight, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on March 4, 1992 after a review of 93 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.

View all American Sunlight, Inc. devices

Submission Details

510(k) Number K915426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1991
Decision Date March 04, 1992
Days to Decision 93 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
22d faster than avg
Panel avg: 115d · This submission: 93d
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.