The following data is part of a premarket notification filed by Intelligent Sensory Concept Sa with the FDA for Elyx-pro.
| Device ID | K162851 |
| 510k Number | K162851 |
| Device Name: | ELyx-PRO |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Intelligent Sensory Concept SA Rue Du Tasson 3 Senarclens, CH 1304 |
| Contact | Joel Chanteraud |
| Correspondent | Rafael Charra BIOLUX INSTITUTE SARL 1 PLACE DE LA MEDITERRANEE Palavas-les-flots, FR 34250 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-11 |
| Decision Date | 2017-01-24 |
| Summary: | summary |