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

Substantially Equivalent

Reimers and Janssen GmbH

FDA 510(k) clearance K131080 for PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE, Substantially Equivalent on 2014-06-13. Applicant: Reimers and Janssen GmbH.

Clearance details

Applicant: Reimers and Janssen GmbH
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2013-03-25
Decision date: 2014-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waldkirch, Baden Wurthemberg, DE

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Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.