The following data is part of a premarket notification filed by Laser-optik-systeme Gmbh & Co. Kg with the FDA for Cold Light Source Los 150.
| Device ID | K951829 |
| 510k Number | K951829 |
| Device Name: | COLD LIGHT SOURCE LOS 150 |
| Classification | Source, Carrier, Fiberoptic Light |
| Applicant | LASER-OPTIK-SYSTEME GMBH & CO. KG AM SAGEWERK 11 Mainz, DE 55124 |
| Product Code | EQH |
| CFR Regulation Number | 874.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-20 |
| Decision Date | 1995-07-10 |