The following data is part of a premarket notification filed by Reimers And Janssen Gmbh with the FDA for Physiolaser Olympic, Single Probes Cw, Cluster Probes Cw, Light Needle, Photonic Satellite.
| Device ID | K131080 |
| 510k Number | K131080 |
| Device Name: | PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | REIMERS AND JANSSEN GMBH FABRIKSTR. 22 Waldkirch, Baden Wurthemberg, DE 79183 |
| Contact | Josephus Janssen |
| Correspondent | Josephus Janssen REIMERS AND JANSSEN GMBH FABRIKSTR. 22 Waldkirch, Baden Wurthemberg, DE 79183 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-25 |
| Decision Date | 2014-06-13 |