The following data is part of a premarket notification filed by Laser Industries Ltd. with the FDA for Laser Rectoscope Set 784.
| Device ID | K842997 |
| 510k Number | K842997 |
| Device Name: | LASER RECTOSCOPE SET 784 |
| Classification | Resectoscope, Working Element |
| Applicant | LASER INDUSTRIES LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FDC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-30 |
| Decision Date | 1984-08-27 |