Cleared Traditional

K131080 - PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE (FDA 510(k) Clearance)

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

K131080 · Reimers and Janssen GmbH · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 228
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K131080.
CureLight Medical Diode Laser Systems (CureLight F2-A15
K253965 · Wuhan PHOMED Technology Company , Ltd. · Mar 2026
Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
K242755 · Gigaalaser Company , Ltd. · May 2025
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
K231997 · Cure Point Therapeutics, Inc. · Oct 2024
LED Lip Perfector, model: ZC-05
K223642 · Light Tree Ventures Europe B.V. · Mar 2023
OLIZ LTB-1000A
K221189 · Ltbio Co., Ltd. · Aug 2022
CytonPro-5000
K213524 · Cytonsys, Inc. · Aug 2022