Cleared Traditional

K903660 - DERMALIGHT PSORACOMB (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903660 · Solitec GmbH · Physical Medicine device
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Jul 1991
Decision
341d
Days
Class 2
Risk

K903660 is an FDA 510(k) clearance for the DERMALIGHT PSORACOMB. Classified as Lamp, Infrared, Non Heating (product code IOB), Class II - Special Controls.

Submitted by Solitec GmbH (Planegg, DE). The FDA issued a Cleared decision on July 17, 1991 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Solitec GmbH devices

Submission Details

510(k) Number K903660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1990
Decision Date July 17, 1991
Days to Decision 341 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 115d · This submission: 341d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IOB Lamp, Infrared, Non Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 Physical Medicine devices follow this clearance model.