The following data is part of a premarket notification filed by Laser Optik Systeme Gmbh & Co. Kg with the FDA for Xenon Light Source Pes 1.
| Device ID | K992540 |
| 510k Number | K992540 |
| Device Name: | XENON LIGHT SOURCE PES 1 |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | LASER OPTIK SYSTEME GMBH & CO. KG AM SAGEWERK 11,6500 MAINZ 23 AMTSGERICHT MAINZ HRB 4527 Germany, DE |
| Contact | R. Happersberger |
| Correspondent | R. Happersberger LASER OPTIK SYSTEME GMBH & CO. KG AM SAGEWERK 11,6500 MAINZ 23 AMTSGERICHT MAINZ HRB 4527 Germany, DE |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-29 |
| Decision Date | 1999-09-14 |