The following data is part of a premarket notification filed by Laser Optik Systeme Gmbh & Co. Kg with the FDA for Los 3d Vision 100.
| Device ID | K953419 |
| 510k Number | K953419 |
| Device Name: | LOS 3D VISION 100 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LASER OPTIK SYSTEME GMBH & CO. KG AM SAGEWERK 11 AMTSGERICHT MAINZ HRB 4527 Mainz, DE 55124 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-03 |
| Decision Date | 1996-02-08 |