PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE— 510(k) K131080
Substantially EquivalentReimers 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. Device class: 2.
Clearance details
- Applicant
- Reimers and Janssen GmbH
- Product code
- Code ILY
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waldkirch, Baden Wurthemberg, DE
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More clearances from Reimers and Janssen GmbH
view allAdverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . 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.