Cleared Traditional

K131080 - PHYSIOLASER OLYMPIC

K131080 is an FDA 510(k) clearance for PHYSIOLASER OLYMPIC, manufactured by Reimers and Janssen GmbH. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 445-day FDA review.

K131080 · Reimers and Janssen GmbH · Physical Medicine device
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Jun 2014
Decision
445d
Days
Class 2
Risk

K131080 is an FDA 510(k) clearance for the PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTO.... Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Reimers and Janssen GmbH (Waldkirch, Baden Wurthemberg, DE). The FDA issued a Cleared decision on June 13, 2014 after a review of 445 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Reimers and Janssen GmbH devices

FDA 510(k) Submission Details - K131080

510(k) Number K131080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2013
Decision Date June 13, 2014
Days to Decision 445 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
330d slower than avg
Panel avg: 115d · This submission: 445d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic 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.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

All 31
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