Cleared Traditional

K903660 - DERMALIGHT PSORACOMB

K903660 is an FDA 510(k) clearance for DERMALIGHT PSORACOMB, manufactured by Solitec GmbH. The device is a Class 2 Physical Medicine device with product code IOB cleared through the Traditional 510(k) pathway after a 341-day FDA review.

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

FDA 510(k) Submission Details - K903660

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.

IOB Device Classification - Class 2, Special Controls

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.